Intestinal Permability
Conditions
Keywords
intestinal permability
Brief summary
The goal of this clinical trial is to evaluate the effects of 45 days daily administration of three different doses (2.5g, 5g, and 10g) of collagen peptide in healthy adults as compared to a Placebo on intestinal permeability following an acute aspirin challenge. The main question it aims to answer is change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide, respectively as compared to a Placebo on intestinal permeability measured by the urinary lactulose : mannitol ratio (test collected over a period of 5 hours).
Interventions
DIETARY_SUPPLEMENTAP GUT collagen peptides
AP GUT collagen peptides
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Rousselot BVBA
Atlantia Food Clinical Trials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be able to give written informed consent. 2. Be between 18-65 years (inclusive) 3. Gastrointestinal symptoms confirmed by an average GSRS-IBS score between ≥2.5 and ≤4.5 at Visit 1 and Visit 2 (+0.5). 4. If Participant has used aspirin in the past and they have not experienced adverse events. 5. Willing to avoid alcohol consumption 2 days prior to each permeability test. 6. Willing to refrain from lactulose, sugar substitutes, and sucralose or mannitol-containing products, for 24-hours prior to the urine collection period. 7. Willing to consume the study product daily for the duration of the study.
Exclusion criteria
1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding. 2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: 1. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit). 2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant. 3. Sexual partner(s) is/are exclusively female. 4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study. 5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study. 3. DASS-21 Depression score of \>21 at screening. 4. Has a history of drug and/or alcohol abuse. (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); alcohol/substance abuse disorder). 5. Has food allergies or other issues with foods that would preclude intake of the Study Products 6. Lactose intolerance 7. Vegetarians not willing to consume animal-based food supplement. 8. Intolerant to aspirin. 9. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include: 1. Diagnosed gastrointestinal condition 2. Severe or uncontrolled cardiovascular disease 3. Severe renal disease/ renal impairment 4. Liver disease 5. Diabetes 6. Any known bleeding disorder 10. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include: 1. Medications affecting gut/intestinal motility (2 weeks prior to visit 1) 2. Daily usage of non-steroidal anti-inflammatory drugs (NSAIDs) in the last 2 months or incidental use in the last 2 weeks prior to screening 3. Antibiotics (4 weeks prior to visit 1) 11. Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include: 1. Collagen supplements (e.g., for bone and joint health and/or skin) 2. Supplements effecting gut motility (e.g. iron, magnesium citrate) 3. Cannabidiol or hemp containing products or supplements 4. Probiotics 5. Prebiotics 6. Postbiotics 12. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. 13. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal permeability | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide respectively as compared to a Placebo on intestinal permeability measured by the urinary lactulose : mannitol ratio (test collected over a period of 5 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal permeability | Day 42 to day 45 | Change from Day 42 to day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary lactulose excretion |
| Gastrointestinal symptoms | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo as measured by Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) -Irritable Bowel Syndrome (IBS) Total score. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable. |
| Concentration of bacterial endotoxins | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Bacterial endotoxins (LPS-binding protein (LBP)) |
| Concentration of intestinal permeability markers/ tight junction dysfunction Markers | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal permeability markers (Occludin, Zonulin) |
| Concentration of an intestinal damage marker | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal damage markers (Intestinal fatty acid binding protein (I-FABP)) |
| Concentration of cytokines | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Cytokines (TNFa, IFNg, IL6, IL1b, IL17 and IL10) |
| Concentration of an Inflammation marker | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Inflammation marker (Calprotectin) |
| Quality of life Physical Component Summary | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 Physical Component Summary Score, The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. |
| Quality of Life Mental Component Summary | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 Mental Component Summary Score, The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. |
| Stress | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Stress as assessed by DASS-21 - Stress scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms. |
| Anxiety | Day 42 to Day 45 | Change from Day 42 to Day 45 following an acute aspirin challenge (NSAID) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Anxiety as assessed by DASS-21 - Anxiety scores. The Depression Anxiety Stress Scales-21 (DASS-21) produces subscale scores based on summed item responses on a 4-point Likert scale (0-3), with higher scores indicating greater severity of symptoms. |
| Percentage urinary lactulose excretion | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on intestinal permeability as measured by 5h % urinary lactulose excretion |
| Concentration of intestinal permeability markers | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal permeability markers (Occludin, Zonulin) |
| Concentration if intestinal damage marker | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Intestinal damage markers (Intestinal fatty acid binding protein (I-FABP)) |
| Concentration of Cytokines | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Cytokines (TNFa, IFNg, IL6, IL1b, IL17 and IL10) |
| Concentration of an inflammation marker | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Inflammation marker (Calprotectin) |
| Quality of life as assessed by SF-12- Physical Component Summary | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 PCS (Physical Component Summary). The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. |
| Quality of life - Mental Component Summary | Baseline to Day 42 | Change from Baseline to Day 42 (prior to aspirin challenge) between three different doses (2.5g, 5g, and 10g) of collagen peptide as compared to a Placebo on Quality of life as assessed by SF-12 MCS (Mental Component Summary). The Short Form 12 Health Survey (SF-12) produces Component Summary scores using norm-based scoring (mean 50, standard deviation 10), with higher scores indicating better health-related quality of life. |
Countries
Ireland
Contacts
CONTACTAndrea Doolan
Outcome results
None listed