Gastrointestinal Tolerance, Healthy Population
Conditions
Keywords
Sugar replacer, Gastrointestinal symptoms, BHD-BSS, GITQ, Acute
Brief summary
This study is a randomized, single-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of a sugar replacer blend (inulin + soluble corn fiber + erythritol) at 3 different doses
Detailed description
The study will have a randomized, single-blind, crossover design with 5 visits consisting of one screening visit and 4 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 3 test products made with the sugar replacer blend over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and \ 1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (Abdominal bloating, Abdominal pain/discomfort, Gas/flatulence, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Nausea and Vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated using the using the Bristol Stool Scale (BSS).
Interventions
OTHERLow-sugar candies compared to regular sugar candies
Acute intake
Sponsors
INQUIS Clinical Research
Mondelēz International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The products will be labelled with a code and participants will not be informed which test meal is which. However, since the portion sizes of some of the treatments differ, some information about them may be available to participants and study coordinators; that is why we have termed the study single blind. Single blinding will be achieved by identifying the treatments by code on the case report forms and in the database, so that those doing the statistical analysis and the study sponsor will be unaware of the treatment assignments.
Intervention model description
In a 4-way cross-over, there is a set of 4 balanced sequences to which participants will be randomly assigned (ABCD, BADC, CDAB, DCBA). Blocks of 2, 3, or 4 sets of sequences were randomly ordered to create a balanced sequence for n=60 participants. Orders will be assigned to participants in the order they attended for the first visit after being recruited.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive * BMI 18.5-32.0kg/m², inclusive * No major illness, trauma or surgery requiring hospitalization within 3mo of the screening visit * Ability to understand the study procedures and willing to provide informed consent to participate in the study * Non-smokers or smokers who smoke \<10 cigarettes/day and are willing not to change nicotine habits during the study period * Willing to limit alcohol consumption to ≤3 standard drinks/d and ≤7 standard drinks/week during the study period * Willing to refrain from any marijuana or hemp products during the study period * Normal bowel habits (\>2 bowel movements/week and \<3 bowel movements per day) * Consumes ≤4 servings/d of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/d of whole grains using the definitions of serving . * Participants must have a cell phone/tablet/computer and be willing and able to use it to collect study data * Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP * Participants are willing to follow current COVID guidelines with respect to attending study visits
Exclusion criteria
* Failure to meet any one of the inclusion criteria * Chronic moderate to severe gastrointestinal symptoms * Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period * Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements) * Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator * Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines * Known intolerance, sensitivity, or allergy to any ingredients in the study test products * Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score | tAUC between 0 and 24 hours | total area under the curve (tAUC) of the composite GastroIntestinal symptom score (sum of the scores for the 8 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of composite score > 1 at each time point | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours | Proportion of participants who have a composite GastoInestinal symptom score \>1 (moderate-to-severe) at each time point. The composite score can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions). |
| Stool consistency based on britol stool scale | Evaluation performed over 24 hour after consumption of study products | mean stool consistency on Bristol Stool Scale (BSS). The scale provide values from 1 to 7 depending on the type of stool with 1 being the driest stools and 7 the most liquid one. |
| Frequency of Diarrhea within 24 hours | Evaluation performed over 24 hour after consumption of study products | Proportion of participants with diarrhea, defined as 3 or more type 6 or 7 stools (based on the BSS) within the 24 hour period after consumption of the study products |
| Maximum score and time for maximum score for each gastrointestinal symptom | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours | For each individual GI symptom: the proportion of participants reporting any (score\>0) or moderate/severe (score \>1) at each time point, the maximum detected score (which can range from 0 up to 3) and the time of the maximum score |
| Total Area Under the Curve of each individual gastrointestinal symptom | tAUC between 0 and 24 hours | Total Area Under the Curve of each of the individual 8 gastrointestinal symptoms. Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms |
| straining during bowel movement | Evaluation performed over 24 hour after consumption of study products | Proportion of participants having to strain or not |
| discomfort during bowel movement | Evaluation performed over 24 hour after consumption of study products | Proportion of participants having discomfort or not |
| incomplete evacuation | Evaluation performed over 24 hour after consumption of study products | Proportion of participants declaring incomplete evacuation or not |
| Number of bowel movements | Evaluation performed over 24 hour after consumption of study products | Number of bowel movements over the 24 hours |
Countries
Canada
Contacts
Primary ContactThomas MS Wolever, aMD, PhD
Backup ContactAlexandra Meynier, PhD
Outcome results
None listed