Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits

This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance; Healthy Population
• Intervention / Treatment: Other: Control sandwiched biscuit with sugar; Other: Test sandwiched biscuits with creme

Detailed Description

The study will have a randomized, double-blind, crossover design with 8 visits consisting of one screening visit and 7 study visits (3 to 14-day interval between the start of each visit) across 4-12 weeks. Participants will be randomized to a test sequence and, during the course of the study, will complete 7 trial arms. At each visit eligible participants will come to INQUIS between 8-11am, and ~1-2h after consuming their usual breakfast at home. After rating the severity of GI symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting. The severity of each symptom will be rated by the subject as None, Mild, Moderate or Severe (these ratings will be assigned scores of 0, 1, 2 or 3, respectively). For each bowel movement (BM) passed during the 24h period, participants will be asked to record: the time, if they had to strain (yes or no), if they experienced discomfort (yes or no), if they felt there was incomplete evacuation (yes or no), if they had oily evacuation (oil separated from the stools) (yes or no), if they had oily stool (oily lumps in the stool) (yes or no) and the consistency of the stool rated using the using the Bristol Stool Scale (BSS).

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • INQUIS Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control biscuit; Sandwiched biscuit with usual sugar and fat content (2 servings = 60g)	Other: Control sandwiched biscuit with sugar; Acute intake
Active Comparator: Control biscuit reduced in fat with EPG; Sandwiched biscuit with usual sugar content and fat partly replaced by EPG in basecake (2 servings = 60g)	Other: Test sandwiched biscuits with creme; Acute intake
Active Comparator: Sugar reduced biscuit with blend 1; Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 (2 servings = 60g)	Other: Test sandwiched biscuits with creme; Acute intake
Active Comparator: Sugar reduced biscuit with blend 1 + EPG in basecake; Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 and EPG replacing fat in basecake (2 servings = 60g)	Other: Test sandwiched biscuits with creme; Acute intake
Active Comparator: Sugar reduced biscuit with blend 1 + EPG in basecake & creme; Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 and EPG replacing fat in basecake & creme (2 servings = 60g)	Other: Test sandwiched biscuits with creme; Acute intake
Active Comparator: Sugar reduced biscuit with blend 2; Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 (2 servings = 60g)	Other: Test sandwiched biscuits with creme; Acute intake
Active Comparator: Sugar reduced biscuit with blend 2 + EPG in basecake; Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 and EPG replacing fat in basecake (2 servings = 60g)	Other: Test sandwiched biscuits with creme; Acute intake

What is the study measuring?

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 11 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
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
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
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
Maximum score for abdominal bloating	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal bloating	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal pain	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal pain	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of maximum score for abdominal pain	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for flatulence	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for burping	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for reflux	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for stomach rumbling	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for nausea	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for vomiting	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Stool consistency based on bristol 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
Total Area Under the Curve of each individual gastrointestinal symptom	Total Area Under the Curve of each of the individual 11 gastrointestinal symptoms (Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting). Each symptom range from 0 up to 3 with 3 showing the highest / worse condiiton of symptoms	tAUC between 0 and 24 hours
Time for maximum score for abdominal bloating	Time of the maximum score for bloating	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for gas with discharge	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for gas with discharge	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for gas with discharge	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for Oily spotting (leakage)	Time of the maximum score	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for Evaluation oily spotting (leakage)	Proportion of participants reporting any (score>0) or moderate/severe (score >1) at each time point	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for oily spotting (leakage)	Maximum detected score (which can range from 0 up to 3)	Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
oily evacuation (oil separated from the stools)	Proportion of participants declaring having oily evacuation (oil separated from the stools)	Evaluation performed over 24 hour after consumption of study products
oily stool (oily lumps in the stool)	Proportion of participants declaring having oily stool (oily lumps in the stool)	Evaluation performed over 24 hour after consumption of study products

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: INQUIS Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: July 23, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acute; gastrointestinal symptoms; sugar replacers; Gastrointestinal Tolerance Questionnaire (GITQ); fat replacer; Bowel Habits - Bristol Stool Scale (BHD-BSS); Biscuits
• Additional Relevant MeSH Terms: Carbohydrates; Sugars
• Other Study ID Numbers: KBE073 / INQ-2405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No