Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies

Conditions
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Gastrointestinal Tolerance, Healthy Population

Intervention / Treatment
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* Other: Low-sugar candies compared to regular sugar candies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control sugar candies<br>Control chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings) | Other: Low-sugar candies compared to regular sugar candies<br>* Acute intake<br>|
| Active Comparator: Test low sugar candies dose 1<br>low-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings) | Other: Low-sugar candies compared to regular sugar candies<br>* Acute intake<br>|
| Active Comparator: Test low sugar candies dose 2<br>64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) | Other: Low-sugar candies compared to regular sugar candies<br>* Acute intake<br>|
| Active Comparator: Test low sugar candies dose 3<br>82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings) | Other: Low-sugar candies compared to regular sugar candies<br>* Acute intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score | 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). | tAUC between 0 and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Area Under the Curve of each individual gastrointestinal symptom | 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 | tAUC between 0 and 24 hours | 
| Frequency of composite score > 1 at each time point | 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). | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours | 
| Frequency of Diarrhea within 24 hours | 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 | Evaluation performed over 24 hour after consumption of study products | 
| Maximum score and time for maximum score for each gastrointestinal symptom | 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 | Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours | 
| Number of bowel movements | Number of bowel movements over the 24 hours | Evaluation performed over 24 hour after consumption of study products | 
| straining during bowel movement | Proportion of participants having to strain or not | Evaluation performed over 24 hour after consumption of study products | 
| discomfort during bowel movement | Proportion of participants having discomfort or not | Evaluation performed over 24 hour after consumption of study products | 
| incomplete evacuation | Proportion of participants declaring incomplete evacuation or not | Evaluation performed over 24 hour after consumption of study products | 
| Stool consistency based on britol stool scale | 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. | Evaluation performed over 24 hour after consumption of study products | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugar replacer, Gastrointestinal symptoms, BHD-BSS, GITQ, Acute