Functional Constipation
Conditions
Keywords
Constipation, Polydextrose, Dietary Fiber, PAC-QoL, Colonic Transit Time, PAC-SYM
Brief summary
This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.
Interventions
DIETARY_SUPPLEMENTLitesse powder containing 12 g polydextrose
12 g polydextrose
DIETARY_SUPPLEMENTLitesse powder containing 8 g polydextrose
8 g polydextrose, 4 g maltodextrin
DIETARY_SUPPLEMENTLitesse powder containing 4 g polydextrose
4 g polydextrose, 8 g maltodextrin
DIETARY_SUPPLEMENTPlacebo
12 g Maltodextrin
Sponsors
DuPont Nutrition and Health
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 18 and 70 years. 2. Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight). 3. If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner). 4. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis): Must meet 2 or more of the following criteria: Straining during at least 25% of defecations, Lumpy or hard stools in at least 25% of defecations, Sensation of incomplete evacuation for at least 25% of defecations, Sensation of anorectal obstruction/blockage for at least 25% of defecations, Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) Fewer than three defecations per week Loose stools are rarely present without the use of laxatives Insufficient criteria for irritable bowel syndrome 5. Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects. 6. Consent to the study and willing to comply with study product and methods. 7. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion criteria
1. Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease) 2. Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results. 3. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness). 4. Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products. 5. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study). 6. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening. 7. Anticipated major dietary or exercise changes during the study. 8. Systemic steroid use, within 1 month before screening. 9. Eating disorder. 10. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product). 11. History of alcohol, drug, or medication abuse. 12. Pregnant or lactating female, or pregnancy planned during study period. 13. Participation in another study with any investigational product within 60 days of screening. 14. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study. 15. Subject under administrative or legal supervision. 16. Subject who would receive more than 4500 Euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Colonic Transit Time From Baseline to Day 15 | Baseline and Day 15 | Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Baseline and Day 15 | Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score) The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires. The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items. |
| Change in Bowel Function Index From Baseline to Day 15 | Baseline and Day 15 | Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions. |
| Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Baseline and Day 15 | Assessed using single question dichotomous tool. Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation. |
| Change in Stool Frequency From Baseline to Day 15 | 14 day run-in and Week 2 of the 14-day supplementation period | Participants will record the number of defecations per day in a daily diary |
| Change in Stool Consistency From Baseline to Day 15 | 14 day run-in and Week 2 of the 14-day supplementation period | Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form. Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5. |
| Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Baseline and Day 15 | Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score). The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales. All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score. |
| Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 | 14 day run-in and Week 2 of the 14-day supplementation period | Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous yes or no scale. The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2. |
| Change in the Severity of Abdominal Discomfort From Baseline to Day 15 | 14 day run-in and Week 2 of the 14-day supplementation period | Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining. |
| Change in the Bloating Severity From Baseline to Day 15 | 14 day run-in and Week 2 of the 14-day supplementation period | Severity of bloating will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining. |
| Overall Product Satisfaction | Assessed at Day 15 (end of study) | Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale. The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement. |
| Change in the Degree of Straining During Defecation From Baseline to Day 15 | 14 day run-in and Week 2 of the 14-day supplementation period | Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale. The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Eosinophil Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure). |
| Change in Basophil Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure). |
| Change in Serum Glucose Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure). |
| Change in Creatinine Levels in Blood From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure). |
| Change in Serum Urea Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure). |
| Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure). |
| Change in Serum Sodium Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure). |
| Change in Serum Potassium Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure). |
| Change in Serum Chloride Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure). |
| Change in Serum Calcium Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure). |
| Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure). |
| Change in Serum Phosphate Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure). |
| Change in Serum Bilirubin Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure). |
| Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure). |
| Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure). |
| Change in Hemoglobin Levels From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome). |
| Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure). |
| Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure). |
| Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values. |
| Change in pH Urinalysis Parameter From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values. |
| Number of Subjects With Adverse Events | 14 days run-in and 14 days treatment | Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure. |
| Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure). |
| Change in Hematocrit Levels From Screening to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome). |
| Change in White Blood Cell Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure). |
| Change in Red Blood Cell Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure). |
| Change in Mean Corpuscular Volume From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure). |
| Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure). |
| Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure). |
| Change in Red Cell Distribution Width From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure). |
| Change in Platelet Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure). |
| Change in Neutrophil Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure). |
| Change in Lymphocyte Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure). |
| Change in Monocyte Count From Baseline to Day 15 | Screening and Day 15 (end of study) | Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Litesse Powder Containing 12 g Polydextrose 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Litesse powder containing 12 g polydextrose: 12 g polydextrose | 48 |
| Litesse Powder Containing 8 g Polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin | 48 |
| Litesse Powder Containing 4 g Polydextrose 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin | 48 |
| Placebo Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks
Placebo: 12 g Maltodextrin | 48 |
| Total | 192 |
Baseline characteristics
| Characteristic | Total | Litesse Powder Containing 12 g Polydextrose | Litesse Powder Containing 8 g Polydextrose | Litesse Powder Containing 4 g Polydextrose | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 14.8 | 42.9 years STANDARD_DEVIATION 16.3 | 42.9 years STANDARD_DEVIATION 12.5 | 41.5 years STANDARD_DEVIATION 17.1 | 43.6 years STANDARD_DEVIATION 13.4 |
| Alcohol Use Daily | 5 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants |
| Alcohol Use None | 32 Participants | 9 Participants | 5 Participants | 9 Participants | 9 Participants |
| Alcohol Use Occasionally | 100 Participants | 27 Participants | 25 Participants | 21 Participants | 27 Participants |
| Alcohol Use Weekly | 55 Participants | 12 Participants | 16 Participants | 16 Participants | 11 Participants |
| Body Mass Index | 25.28 kg/m^2 STANDARD_DEVIATION 2.85 | 25.27 kg/m^2 STANDARD_DEVIATION 3.06 | 25.31 kg/m^2 STANDARD_DEVIATION 3.09 | 25.32 kg/m^2 STANDARD_DEVIATION 2.82 | 25.23 kg/m^2 STANDARD_DEVIATION 2.48 |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Central American | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized East Asian | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Eastern European White | 8 Participants | 0 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Middle Eastern | 6 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized North American Indian | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized South American | 12 Participants | 0 Participants | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized South Asian | 5 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized South East Asian | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Western European White | 147 Participants | 36 Participants | 36 Participants | 40 Participants | 35 Participants |
| Sex: Female, Male Female | 133 Participants | 34 Participants | 34 Participants | 32 Participants | 33 Participants |
| Sex: Female, Male Male | 59 Participants | 14 Participants | 14 Participants | 16 Participants | 15 Participants |
| Smoking Status Current Smoker | 22 Participants | 7 Participants | 4 Participants | 5 Participants | 6 Participants |
| Smoking Status Ex-Smoker | 25 Participants | 7 Participants | 8 Participants | 3 Participants | 7 Participants |
| Smoking Status Non-Smoker | 145 Participants | 34 Participants | 36 Participants | 40 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 48 | 10 / 48 | 1 / 48 | 11 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 | 0 / 48 | 0 / 48 |
Outcome results
Primary
Change in Colonic Transit Time From Baseline to Day 15
Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.
Time frame: Baseline and Day 15
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Colonic Transit Time From Baseline to Day 15 | -1.7 Hours | Standard Deviation 23.6 |
| Litesse Powder Containing 8 g Polydextrose | Change in Colonic Transit Time From Baseline to Day 15 | 4.0 Hours | Standard Deviation 23.4 |
| Litesse Powder Containing 4 g Polydextrose | Change in Colonic Transit Time From Baseline to Day 15 | 2.5 Hours | Standard Deviation 23.7 |
| Placebo | Change in Colonic Transit Time From Baseline to Day 15 | 2.6 Hours | Standard Deviation 25.9 |
Secondary
Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15
Assessed using single question dichotomous tool. Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.
Time frame: Baseline and Day 15
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Day 14 End-of-Study | 36 Participants |
| Litesse Powder Containing 12 g Polydextrose | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Baseline | 24 Participants |
| Litesse Powder Containing 8 g Polydextrose | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Baseline | 25 Participants |
| Litesse Powder Containing 8 g Polydextrose | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Day 14 End-of-Study | 31 Participants |
| Litesse Powder Containing 4 g Polydextrose | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Day 14 End-of-Study | 20 Participants |
| Litesse Powder Containing 4 g Polydextrose | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Baseline | 19 Participants |
| Placebo | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Day 14 End-of-Study | 26 Participants |
| Placebo | Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 | Relief at Baseline | 16 Participants |
Secondary
Change in Bowel Function Index From Baseline to Day 15
Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.
Time frame: Baseline and Day 15
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Feeling of Incomplete Bowel Evacuation | -11.6 scores on a scale | Standard Deviation 30.1 |
| Litesse Powder Containing 12 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Ease of Defecation | -6.2 scores on a scale | Standard Deviation 32.8 |
| Litesse Powder Containing 12 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Overall Score | -9.3 scores on a scale | Standard Deviation 23.6 |
| Litesse Powder Containing 12 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Personal Judgement of Constipation | -10.1 scores on a scale | Standard Deviation 27.3 |
| Litesse Powder Containing 8 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Ease of Defecation | -6.2 scores on a scale | Standard Deviation 26.1 |
| Litesse Powder Containing 8 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Overall Score | -8.2 scores on a scale | Standard Deviation 20.8 |
| Litesse Powder Containing 8 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Feeling of Incomplete Bowel Evacuation | -10.9 scores on a scale | Standard Deviation 31.5 |
| Litesse Powder Containing 8 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Personal Judgement of Constipation | -7.5 scores on a scale | Standard Deviation 24.3 |
| Litesse Powder Containing 4 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Overall Score | -8.9 scores on a scale | Standard Deviation 20.1 |
| Litesse Powder Containing 4 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Feeling of Incomplete Bowel Evacuation | -15.1 scores on a scale | Standard Deviation 23.3 |
| Litesse Powder Containing 4 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Ease of Defecation | -5.9 scores on a scale | Standard Deviation 26.2 |
| Litesse Powder Containing 4 g Polydextrose | Change in Bowel Function Index From Baseline to Day 15 | Personal Judgement of Constipation | -5.7 scores on a scale | Standard Deviation 20.9 |
| Placebo | Change in Bowel Function Index From Baseline to Day 15 | Ease of Defecation | -8.8 scores on a scale | Standard Deviation 25.8 |
| Placebo | Change in Bowel Function Index From Baseline to Day 15 | Feeling of Incomplete Bowel Evacuation | -9.5 scores on a scale | Standard Deviation 34 |
| Placebo | Change in Bowel Function Index From Baseline to Day 15 | Personal Judgement of Constipation | -12.4 scores on a scale | Standard Deviation 27.6 |
| Placebo | Change in Bowel Function Index From Baseline to Day 15 | Overall Score | -10.2 scores on a scale | Standard Deviation 23.4 |
Secondary
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15
Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score) The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires. The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.
Time frame: Baseline and Day 15
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Psychosocial Discomfort Score | -0.12 scores on a scale | Standard Deviation 0.53 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Physical Discomfort Score | -0.24 scores on a scale | Standard Deviation 0.74 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Satisfaction Score | 0.44 scores on a scale | Standard Deviation 0.98 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Worries and Concerns Score | -0.27 scores on a scale | Standard Deviation 0.59 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Overall Score | -0.05 scores on a scale | Standard Deviation 0.36 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Overall Score | -0.04 scores on a scale | Standard Deviation 0.45 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Worries and Concerns Score | -0.17 scores on a scale | Standard Deviation 0.54 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Physical Discomfort Score | -0.23 scores on a scale | Standard Deviation 0.73 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Psychosocial Discomfort Score | -0.11 scores on a scale | Standard Deviation 0.58 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Satisfaction Score | 0.37 scores on a scale | Standard Deviation 0.75 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Psychosocial Discomfort Score | -0.17 scores on a scale | Standard Deviation 0.52 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Overall Score | -0.08 scores on a scale | Standard Deviation 0.33 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Worries and Concerns Score | -0.15 scores on a scale | Standard Deviation 0.46 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Satisfaction Score | 0.12 scores on a scale | Standard Deviation 0.67 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Physical Discomfort Score | -0.13 scores on a scale | Standard Deviation 0.58 |
| Placebo | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Overall Score | -0.11 scores on a scale | Standard Deviation 0.33 |
| Placebo | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Satisfaction Score | -0.02 scores on a scale | Standard Deviation 0.69 |
| Placebo | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Psychosocial Discomfort Score | -0.09 scores on a scale | Standard Deviation 0.53 |
| Placebo | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Physical Discomfort Score | -0.20 scores on a scale | Standard Deviation 0.75 |
| Placebo | Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 | Worries and Concerns Score | -0.13 scores on a scale | Standard Deviation 0.6 |
Secondary
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15
Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score). The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales. All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.
Time frame: Baseline and Day 15
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Rectal Symptoms Score | -0.28 scores on a scale | Standard Deviation 0.71 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Abdominal Symptoms Score | -0.13 scores on a scale | Standard Deviation 0.69 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Overall Score | -0.24 scores on a scale | Standard Deviation 0.59 |
| Litesse Powder Containing 12 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Stool Symptoms Score | -0.31 scores on a scale | Standard Deviation 0.82 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Overall Score | -0.13 scores on a scale | Standard Deviation 0.39 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Rectal Symptoms Score | -0.16 scores on a scale | Standard Deviation 0.46 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Stool Symptoms Score | -0.16 scores on a scale | Standard Deviation 0.68 |
| Litesse Powder Containing 8 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Abdominal Symptoms Score | -0.06 scores on a scale | Standard Deviation 0.51 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Overall Score | -0.04 scores on a scale | Standard Deviation 0.44 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Abdominal Symptoms Score | -0.01 scores on a scale | Standard Deviation 0.56 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Rectal Symptoms Score | 0.06 scores on a scale | Standard Deviation 0.6 |
| Litesse Powder Containing 4 g Polydextrose | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Stool Symptoms Score | -0.18 scores on a scale | Standard Deviation 0.62 |
| Placebo | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Abdominal Symptoms Score | -0.15 scores on a scale | Standard Deviation 0.6 |
| Placebo | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Overall Score | -0.21 scores on a scale | Standard Deviation 0.56 |
| Placebo | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Stool Symptoms Score | -0.28 scores on a scale | Standard Deviation 0.82 |
| Placebo | Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 | Rectal Symptoms Score | -0.21 scores on a scale | Standard Deviation 0.59 |
Secondary
Change in Stool Consistency From Baseline to Day 15
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form. Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.
Time frame: 14 day run-in and Week 2 of the 14-day supplementation period
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Stool Consistency From Baseline to Day 15 | 0.33 scores on a scale | Standard Deviation 0.99 |
| Litesse Powder Containing 8 g Polydextrose | Change in Stool Consistency From Baseline to Day 15 | -0.11 scores on a scale | Standard Deviation 0.95 |
| Litesse Powder Containing 4 g Polydextrose | Change in Stool Consistency From Baseline to Day 15 | 0.30 scores on a scale | Standard Deviation 0.99 |
| Placebo | Change in Stool Consistency From Baseline to Day 15 | 0.13 scores on a scale | Standard Deviation 0.93 |
Secondary
Change in Stool Frequency From Baseline to Day 15
Participants will record the number of defecations per day in a daily diary
Time frame: 14 day run-in and Week 2 of the 14-day supplementation period
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Stool Frequency From Baseline to Day 15 | 1.2 Number of Bowel Movements Per Day | Standard Deviation 3.3 |
| Litesse Powder Containing 8 g Polydextrose | Change in Stool Frequency From Baseline to Day 15 | -0.2 Number of Bowel Movements Per Day | Standard Deviation 3.3 |
| Litesse Powder Containing 4 g Polydextrose | Change in Stool Frequency From Baseline to Day 15 | -0.4 Number of Bowel Movements Per Day | Standard Deviation 2.2 |
| Placebo | Change in Stool Frequency From Baseline to Day 15 | -0.9 Number of Bowel Movements Per Day | Standard Deviation 3.7 |
Secondary
Change in the Bloating Severity From Baseline to Day 15
Severity of bloating will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.
Time frame: 14 day run-in and Week 2 of the 14-day supplementation period
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in the Bloating Severity From Baseline to Day 15 | -0.13 scores on a scale | Standard Deviation 0.58 |
| Litesse Powder Containing 8 g Polydextrose | Change in the Bloating Severity From Baseline to Day 15 | -0.23 scores on a scale | Standard Deviation 0.47 |
| Litesse Powder Containing 4 g Polydextrose | Change in the Bloating Severity From Baseline to Day 15 | -0.12 scores on a scale | Standard Deviation 0.49 |
| Placebo | Change in the Bloating Severity From Baseline to Day 15 | -0.03 scores on a scale | Standard Deviation 0.58 |
Secondary
Change in the Degree of Straining During Defecation From Baseline to Day 15
Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale. The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.
Time frame: 14 day run-in and Week 2 of the 14-day supplementation period
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in the Degree of Straining During Defecation From Baseline to Day 15 | -0.07 scores on a scale | Standard Deviation 0.82 |
| Litesse Powder Containing 8 g Polydextrose | Change in the Degree of Straining During Defecation From Baseline to Day 15 | -0.26 scores on a scale | Standard Deviation 0.87 |
| Litesse Powder Containing 4 g Polydextrose | Change in the Degree of Straining During Defecation From Baseline to Day 15 | -0.15 scores on a scale | Standard Deviation 0.81 |
| Placebo | Change in the Degree of Straining During Defecation From Baseline to Day 15 | -0.09 scores on a scale | Standard Deviation 0.46 |
Secondary
Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15
Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous yes or no scale. The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.
Time frame: 14 day run-in and Week 2 of the 14-day supplementation period
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 | 10.8 Percentage of CBMs per week | Standard Deviation 27.5 |
| Litesse Powder Containing 8 g Polydextrose | Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 | 10.2 Percentage of CBMs per week | Standard Deviation 25.1 |
| Litesse Powder Containing 4 g Polydextrose | Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 | 7.3 Percentage of CBMs per week | Standard Deviation 31.3 |
| Placebo | Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15 | -3.4 Percentage of CBMs per week | Standard Deviation 33.2 |
Secondary
Change in the Severity of Abdominal Discomfort From Baseline to Day 15
Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.
Time frame: 14 day run-in and Week 2 of the 14-day supplementation period
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in the Severity of Abdominal Discomfort From Baseline to Day 15 | 0.06 scores on a scale | Standard Deviation 0.57 |
| Litesse Powder Containing 8 g Polydextrose | Change in the Severity of Abdominal Discomfort From Baseline to Day 15 | -0.05 scores on a scale | Standard Deviation 0.61 |
| Litesse Powder Containing 4 g Polydextrose | Change in the Severity of Abdominal Discomfort From Baseline to Day 15 | -0.10 scores on a scale | Standard Deviation 0.58 |
| Placebo | Change in the Severity of Abdominal Discomfort From Baseline to Day 15 | -0.01 scores on a scale | Standard Deviation 0.44 |
Secondary
Overall Product Satisfaction
Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale. The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.
Time frame: Assessed at Day 15 (end of study)
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Overall Product Satisfaction | 3.26 scores on a scale | Standard Deviation 1.2 |
| Litesse Powder Containing 8 g Polydextrose | Overall Product Satisfaction | 3.09 scores on a scale | Standard Deviation 1.23 |
| Litesse Powder Containing 4 g Polydextrose | Overall Product Satisfaction | 2.54 scores on a scale | Standard Deviation 1.14 |
| Placebo | Overall Product Satisfaction | 2.62 scores on a scale | Standard Deviation 1.15 |
Other Pre-specified
Change in Basophil Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Basophil Count From Baseline to Day 15 | 0.000 10^9 cells/L | Standard Deviation 0.042 |
| Litesse Powder Containing 8 g Polydextrose | Change in Basophil Count From Baseline to Day 15 | 0.008 10^9 cells/L | Standard Deviation 0.05 |
| Litesse Powder Containing 4 g Polydextrose | Change in Basophil Count From Baseline to Day 15 | 0.002 10^9 cells/L | Standard Deviation 0.033 |
| Placebo | Change in Basophil Count From Baseline to Day 15 | 0.010 10^9 cells/L | Standard Deviation 0.037 |
Other Pre-specified
Change in Creatinine Levels in Blood From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Creatinine Levels in Blood From Baseline to Day 15 | 0.8 μmol | Standard Deviation 8.4 |
| Litesse Powder Containing 8 g Polydextrose | Change in Creatinine Levels in Blood From Baseline to Day 15 | -0.1 μmol | Standard Deviation 5.9 |
| Litesse Powder Containing 4 g Polydextrose | Change in Creatinine Levels in Blood From Baseline to Day 15 | 0.6 μmol | Standard Deviation 4.8 |
| Placebo | Change in Creatinine Levels in Blood From Baseline to Day 15 | 0.8 μmol | Standard Deviation 5.4 |
Other Pre-specified
Change in Eosinophil Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Eosinophil Count From Baseline to Day 15 | -0.002 10^9 cells/L | Standard Deviation 0.09 |
| Litesse Powder Containing 8 g Polydextrose | Change in Eosinophil Count From Baseline to Day 15 | -0.025 10^9 cells/L | Standard Deviation 0.076 |
| Litesse Powder Containing 4 g Polydextrose | Change in Eosinophil Count From Baseline to Day 15 | 0.030 10^9 cells/L | Standard Deviation 0.197 |
| Placebo | Change in Eosinophil Count From Baseline to Day 15 | 0.029 10^9 cells/L | Standard Deviation 0.153 |
Other Pre-specified
Change in Hematocrit Levels From Screening to Day 15
Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Hematocrit Levels From Screening to Day 15 | -0.0045 Percentage of red blood cells | Standard Deviation 0.0156 |
| Litesse Powder Containing 8 g Polydextrose | Change in Hematocrit Levels From Screening to Day 15 | -0.0008 Percentage of red blood cells | Standard Deviation 0.0166 |
| Litesse Powder Containing 4 g Polydextrose | Change in Hematocrit Levels From Screening to Day 15 | -0.0057 Percentage of red blood cells | Standard Deviation 0.0141 |
| Placebo | Change in Hematocrit Levels From Screening to Day 15 | 0.0031 Percentage of red blood cells | Standard Deviation 0.0146 |
Other Pre-specified
Change in Hemoglobin Levels From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Hemoglobin Levels From Baseline to Day 15 | -1.0 g/dL | Standard Deviation 5.1 |
| Litesse Powder Containing 8 g Polydextrose | Change in Hemoglobin Levels From Baseline to Day 15 | -0.9 g/dL | Standard Deviation 5.5 |
| Litesse Powder Containing 4 g Polydextrose | Change in Hemoglobin Levels From Baseline to Day 15 | -1.4 g/dL | Standard Deviation 5.1 |
| Placebo | Change in Hemoglobin Levels From Baseline to Day 15 | 0.3 g/dL | Standard Deviation 5.7 |
Other Pre-specified
Change in Lymphocyte Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Lymphocyte Count From Baseline to Day 15 | 0.04 10^9 cells/L | Standard Deviation 0.44 |
| Litesse Powder Containing 8 g Polydextrose | Change in Lymphocyte Count From Baseline to Day 15 | -0.10 10^9 cells/L | Standard Deviation 0.36 |
| Litesse Powder Containing 4 g Polydextrose | Change in Lymphocyte Count From Baseline to Day 15 | -0.01 10^9 cells/L | Standard Deviation 0.39 |
| Placebo | Change in Lymphocyte Count From Baseline to Day 15 | -0.06 10^9 cells/L | Standard Deviation 0.48 |
Other Pre-specified
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 | 0.8 g/dL | Standard Deviation 5.2 |
| Litesse Powder Containing 8 g Polydextrose | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 | -0.9 g/dL | Standard Deviation 5.9 |
| Litesse Powder Containing 4 g Polydextrose | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 | 1.4 g/dL | Standard Deviation 4.7 |
| Placebo | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15 | -1.5 g/dL | Standard Deviation 5.5 |
Other Pre-specified
Change in Mean Corpuscular Hemoglobin From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 | 0.16 pg | Standard Deviation 0.75 |
| Litesse Powder Containing 8 g Polydextrose | Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 | -0.02 pg | Standard Deviation 0.63 |
| Litesse Powder Containing 4 g Polydextrose | Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 | 0.04 pg | Standard Deviation 0.46 |
| Placebo | Change in Mean Corpuscular Hemoglobin From Baseline to Day 15 | -0.15 pg | Standard Deviation 0.54 |
Other Pre-specified
Change in Mean Corpuscular Volume From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Mean Corpuscular Volume From Baseline to Day 15 | 0.10 fL | Standard Deviation 1.13 |
| Litesse Powder Containing 8 g Polydextrose | Change in Mean Corpuscular Volume From Baseline to Day 15 | 0.23 fL | Standard Deviation 1.09 |
| Litesse Powder Containing 4 g Polydextrose | Change in Mean Corpuscular Volume From Baseline to Day 15 | -0.19 fL | Standard Deviation 1.21 |
| Placebo | Change in Mean Corpuscular Volume From Baseline to Day 15 | -0.09 fL | Standard Deviation 1.05 |
Other Pre-specified
Change in Monocyte Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Monocyte Count From Baseline to Day 15 | -0.002 10^9 cells/L | Standard Deviation 0.39 |
| Litesse Powder Containing 8 g Polydextrose | Change in Monocyte Count From Baseline to Day 15 | -0.012 10^9 cells/L | Standard Deviation 0.13 |
| Litesse Powder Containing 4 g Polydextrose | Change in Monocyte Count From Baseline to Day 15 | -0.006 10^9 cells/L | Standard Deviation 0.139 |
| Placebo | Change in Monocyte Count From Baseline to Day 15 | 0.021 10^9 cells/L | Standard Deviation 0.16 |
Other Pre-specified
Change in Neutrophil Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Neutrophil Count From Baseline to Day 15 | 0.10 10^9 cells/L | Standard Deviation 1.43 |
| Litesse Powder Containing 8 g Polydextrose | Change in Neutrophil Count From Baseline to Day 15 | -0.19 10^9 cells/L | Standard Deviation 1 |
| Litesse Powder Containing 4 g Polydextrose | Change in Neutrophil Count From Baseline to Day 15 | -0.19 10^9 cells/L | Standard Deviation 1 |
| Placebo | Change in Neutrophil Count From Baseline to Day 15 | 0.10 10^9 cells/L | Standard Deviation 1.05 |
Other Pre-specified
Change in pH Urinalysis Parameter From Baseline to Day 15
Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values.
Time frame: Screening and Day 15 (end of study)
Population: One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in pH Urinalysis Parameter From Baseline to Day 15 | -0.05 pH | Standard Deviation 0.97 |
| Litesse Powder Containing 8 g Polydextrose | Change in pH Urinalysis Parameter From Baseline to Day 15 | 0.20 pH | Standard Deviation 1.1 |
| Litesse Powder Containing 4 g Polydextrose | Change in pH Urinalysis Parameter From Baseline to Day 15 | 0.02 pH | Standard Deviation 1.02 |
| Placebo | Change in pH Urinalysis Parameter From Baseline to Day 15 | 0.06 pH | Standard Deviation 1.07 |
Other Pre-specified
Change in Platelet Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Platelet Count From Baseline to Day 15 | -3.7 10^9 cells/L | Standard Deviation 20.4 |
| Litesse Powder Containing 8 g Polydextrose | Change in Platelet Count From Baseline to Day 15 | 6.0 10^9 cells/L | Standard Deviation 27 |
| Litesse Powder Containing 4 g Polydextrose | Change in Platelet Count From Baseline to Day 15 | -5.9 10^9 cells/L | Standard Deviation 25.9 |
| Placebo | Change in Platelet Count From Baseline to Day 15 | 1.6 10^9 cells/L | Standard Deviation 29.5 |
Other Pre-specified
Change in Red Blood Cell Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Red Blood Cell Count From Baseline to Day 15 | -0.052 10^12 cells/L | Standard Deviation 0.157 |
| Litesse Powder Containing 8 g Polydextrose | Change in Red Blood Cell Count From Baseline to Day 15 | -0.030 10^12 cells/L | Standard Deviation 0.171 |
| Litesse Powder Containing 4 g Polydextrose | Change in Red Blood Cell Count From Baseline to Day 15 | -0.053 10^12 cells/L | Standard Deviation 0.163 |
| Placebo | Change in Red Blood Cell Count From Baseline to Day 15 | 0.034 10^12 cells/L | Standard Deviation 0.159 |
Other Pre-specified
Change in Red Cell Distribution Width From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Red Cell Distribution Width From Baseline to Day 15 | -0.03 percent of mean red blood cell volume | Standard Deviation 0.35 |
| Litesse Powder Containing 8 g Polydextrose | Change in Red Cell Distribution Width From Baseline to Day 15 | 0.06 percent of mean red blood cell volume | Standard Deviation 0.33 |
| Litesse Powder Containing 4 g Polydextrose | Change in Red Cell Distribution Width From Baseline to Day 15 | -0.03 percent of mean red blood cell volume | Standard Deviation 0.62 |
| Placebo | Change in Red Cell Distribution Width From Baseline to Day 15 | -0.08 percent of mean red blood cell volume | Standard Deviation 0.43 |
Other Pre-specified
Change in Serum Alanine Transaminase Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 | 1.6 U/L | Standard Deviation 7 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 | -0.1 U/L | Standard Deviation 7.7 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 | -1.0 U/L | Standard Deviation 9.5 |
| Placebo | Change in Serum Alanine Transaminase Concentration From Baseline to Day 15 | -0.6 U/L | Standard Deviation 8.2 |
Other Pre-specified
Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 | 1.0 U/L | Standard Deviation 6.7 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 | -0.7 U/L | Standard Deviation 7.7 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 | -1.0 U/L | Standard Deviation 7 |
| Placebo | Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15 | 1.9 U/L | Standard Deviation 9.8 |
Other Pre-specified
Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 | 0.7 U/L | Standard Deviation 4.5 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 | 3.2 U/L | Standard Deviation 16.2 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 | -0.1 U/L | Standard Deviation 7.8 |
| Placebo | Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15 | 0.2 U/L | Standard Deviation 4.9 |
Other Pre-specified
Change in Serum Bilirubin Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Bilirubin Concentration From Baseline to Day 15 | -0.5 μmol/L | Standard Deviation 4 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Bilirubin Concentration From Baseline to Day 15 | 0.6 μmol/L | Standard Deviation 3.3 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Bilirubin Concentration From Baseline to Day 15 | 0.1 μmol/L | Standard Deviation 3.4 |
| Placebo | Change in Serum Bilirubin Concentration From Baseline to Day 15 | 0.6 μmol/L | Standard Deviation 5 |
Other Pre-specified
Change in Serum Calcium Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Calcium Concentration From Baseline to Day 15 | -0.019 mmol/L | Standard Deviation 0.101 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Calcium Concentration From Baseline to Day 15 | 0.016 mmol/L | Standard Deviation 0.092 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Calcium Concentration From Baseline to Day 15 | -0.004 mmol/L | Standard Deviation 0.085 |
| Placebo | Change in Serum Calcium Concentration From Baseline to Day 15 | 0.028 mmol/L | Standard Deviation 0.098 |
Other Pre-specified
Change in Serum Carbon Dioxide Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 | -0.60 mmol/L | Standard Deviation 2.73 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 | 0.31 mmol/L | Standard Deviation 2.49 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 | -0.13 mmol/L | Standard Deviation 2.65 |
| Placebo | Change in Serum Carbon Dioxide Concentration From Baseline to Day 15 | -0.50 mmol/L | Standard Deviation 2.26 |
Other Pre-specified
Change in Serum Chloride Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Chloride Concentration From Baseline to Day 15 | -0.21 mmol/L | Standard Deviation 2.32 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Chloride Concentration From Baseline to Day 15 | -0.004 mmol/L | Standard Deviation 2.4 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Chloride Concentration From Baseline to Day 15 | -0.71 mmol/L | Standard Deviation 2.08 |
| Placebo | Change in Serum Chloride Concentration From Baseline to Day 15 | -0.29 mmol/L | Standard Deviation 2.28 |
Other Pre-specified
Change in Serum C-Reactive Protein Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 | 0.6 mg/L | Standard Deviation 2.6 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 | 0.1 mg/L | Standard Deviation 4.4 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 | -0.2 mg/L | Standard Deviation 2.4 |
| Placebo | Change in Serum C-Reactive Protein Concentration From Baseline to Day 15 | 0.4 mg/L | Standard Deviation 2.6 |
Other Pre-specified
Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 | -1.9 mL/min/1.73m^2 | Standard Deviation 10.8 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 | 1.4 mL/min/1.73m^2 | Standard Deviation 7.8 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 | -0.1 mL/min/1.73m^2 | Standard Deviation 5.6 |
| Placebo | Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15 | -1.9 mL/min/1.73m^2 | Standard Deviation 6.3 |
Other Pre-specified
Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 | 0.6 U/L | Standard Deviation 4 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 | -1.6 U/L | Standard Deviation 6.1 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 | 0.3 U/L | Standard Deviation 6.2 |
| Placebo | Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15 | -2.8 U/L | Standard Deviation 15.3 |
Other Pre-specified
Change in Serum Glucose Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: The number analyzed from the Litesse powder 4g arm is only 47 due to laboratory analysis error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Glucose Concentration From Baseline to Day 15 | -0.12 mmol/L | Standard Deviation 0.42 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Glucose Concentration From Baseline to Day 15 | 0.04 mmol/L | Standard Deviation 0.46 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Glucose Concentration From Baseline to Day 15 | -0.15 mmol/L | Standard Deviation 0.44 |
| Placebo | Change in Serum Glucose Concentration From Baseline to Day 15 | -0.10 mmol/L | Standard Deviation 0.57 |
Other Pre-specified
Change in Serum Phosphate Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Phosphate Concentration From Baseline to Day 15 | 0.011 mmol/L | Standard Deviation 0.147 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Phosphate Concentration From Baseline to Day 15 | -0.034 mmol/L | Standard Deviation 0.165 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Phosphate Concentration From Baseline to Day 15 | 0.012 mmol/L | Standard Deviation 0.168 |
| Placebo | Change in Serum Phosphate Concentration From Baseline to Day 15 | -0.003 mmol/L | Standard Deviation 0.244 |
Other Pre-specified
Change in Serum Potassium Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Potassium Concentration From Baseline to Day 15 | -0.21 mmol/L | Standard Deviation 0.53 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Potassium Concentration From Baseline to Day 15 | -0.01 mmol/L | Standard Deviation 0.61 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Potassium Concentration From Baseline to Day 15 | -0.21 mmol/L | Standard Deviation 0.5 |
| Placebo | Change in Serum Potassium Concentration From Baseline to Day 15 | -0.01 mmol/L | Standard Deviation 0.46 |
Other Pre-specified
Change in Serum Sodium Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Sodium Concentration From Baseline to Day 15 | -0.90 mmol/L | Standard Deviation 2.94 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Sodium Concentration From Baseline to Day 15 | -0.27 mmol/L | Standard Deviation 2.3 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Sodium Concentration From Baseline to Day 15 | -0.83 mmol/L | Standard Deviation 2.6 |
| Placebo | Change in Serum Sodium Concentration From Baseline to Day 15 | -0.19 mmol/L | Standard Deviation 2.5 |
Other Pre-specified
Change in Serum Urea Concentration From Baseline to Day 15
Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure).
Time frame: Screening and Day 15 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Serum Urea Concentration From Baseline to Day 15 | 0.18 mmol/L | Standard Deviation 1.11 |
| Litesse Powder Containing 8 g Polydextrose | Change in Serum Urea Concentration From Baseline to Day 15 | -0.31 mmol/L | Standard Deviation 1 |
| Litesse Powder Containing 4 g Polydextrose | Change in Serum Urea Concentration From Baseline to Day 15 | -0.10 mmol/L | Standard Deviation 1.03 |
| Placebo | Change in Serum Urea Concentration From Baseline to Day 15 | 0.08 mmol/L | Standard Deviation 1.2 |
Other Pre-specified
Change in Specific Gravity Urinalysis Parameter From Screening to Day 15
Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values.
Time frame: Screening and Day 15 (end of study)
Population: One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 | 0.0010 mmol/L | Standard Deviation 0.0072 |
| Litesse Powder Containing 8 g Polydextrose | Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 | 0.0007 mmol/L | Standard Deviation 0.0071 |
| Litesse Powder Containing 4 g Polydextrose | Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 | 0.0005 mmol/L | Standard Deviation 0.0135 |
| Placebo | Change in Specific Gravity Urinalysis Parameter From Screening to Day 15 | 0.0029 mmol/L | Standard Deviation 0.0096 |
Other Pre-specified
Change in White Blood Cell Count From Baseline to Day 15
Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure).
Time frame: Screening and Day 15 (end of study)
Population: Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Change in White Blood Cell Count From Baseline to Day 15 | 0.13 10^9 cells/L | Standard Deviation 1.56 |
| Litesse Powder Containing 8 g Polydextrose | Change in White Blood Cell Count From Baseline to Day 15 | -0.34 10^9 cells/L | Standard Deviation 1.19 |
| Litesse Powder Containing 4 g Polydextrose | Change in White Blood Cell Count From Baseline to Day 15 | -0.19 10^9 cells/L | Standard Deviation 1.24 |
| Placebo | Change in White Blood Cell Count From Baseline to Day 15 | 0.06 10^9 cells/L | Standard Deviation 1.33 |
Other Pre-specified
Number of Subjects With Adverse Events
Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure.
Time frame: 14 days run-in and 14 days treatment
Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Litesse Powder Containing 12 g Polydextrose | Number of Subjects With Adverse Events | 30 Number of Adverse Events |
| Litesse Powder Containing 8 g Polydextrose | Number of Subjects With Adverse Events | 23 Number of Adverse Events |
| Litesse Powder Containing 4 g Polydextrose | Number of Subjects With Adverse Events | 11 Number of Adverse Events |
| Placebo | Number of Subjects With Adverse Events | 29 Number of Adverse Events |