Clinical trial NCT06479330: Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
Official title: Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastrointestinal Tolerance
Healthy Population
Keywords: sugar replacers
gastrointestinal symptoms
Bowel Habits Diary - Bristol Stool Scale (BHD-BSS)
Gastrointestinal Tolerance Questionnaire (GITQ)
Acute
Chocolate
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: INQUIS Clinical Research
First posted: 2024-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In a 5-way cross-over, there is a set of 10 balanced sequences to which participants will be randomly assigned. Blocks of 1 or 2 sets of sequences will be 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.
Primary purpose: PREVENTION

Brief summary: This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses)

Detailed description: The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 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 4 test products made with the sugar replacer ingredients or blend of ingredients 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, 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 Bristol Stool Scale (BSS).

Eligibility criteria: Inclusion Criteria:

* Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
* Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
* No major illness, trauma or surgery requiring hospitalization within 3 months 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/day 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/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day 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 (Ontario Health Insurance Plan)
* 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

Primary outcomes:
measure: Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
timeFrame: tAUC between 0 and 24 hours
Secondary outcomes:
measure: Total Area Under the Curve of each individual gastrointestinal symptom
timeFrame: tAUC between 0 and 24 hours
measure: Frequency of composite score > 1 at each time point
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Frequency of Diarrhea within 24 hours
timeFrame: Evaluation performed over 24 hour after consumption of study products
measure: Time for maximum score for abdominal bloating
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for abdominal bloating
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for abdominal bloating
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for abdominal pain
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for abdominal pain
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time of maximum score for abdominal pain
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for flatulence
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for flatulence
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time for maximum score for flatulence
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for burping
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for burping
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time for maximum score for burping
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for reflux
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for reflux
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time for maximum score for reflux
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for stomach rumbling
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for stomach rumbling
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time for maximum score for stomach rumbling
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for nausea
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for nausea
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time for maximum score for nausea
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for vomiting
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Maximum score for vomiting
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Time for maximum score for vomiting
timeFrame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
measure: Number of bowel movements
timeFrame: Evaluation performed over 24 hour after consumption of study products
measure: straining during bowel movement
timeFrame: Evaluation performed over 24 hour after consumption of study products
measure: discomfort during bowel movement
timeFrame: Evaluation performed over 24 hour after consumption of study products
measure: incomplete evacuation
timeFrame: Evaluation performed over 24 hour after consumption of study products
measure: Stool consistency based on bristol stool scale
timeFrame: Evaluation performed over 24 hour after consumption of study products
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Inquis Clinical Research
state: Ontario
Study officials:
References: