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

NCT07372482 | Completed

• 1 other identifier: KBE073 / INQ-2405
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Gastrointestinal Tolerance; Healthy Population

Keywords

sugar replacers; fat replacer; gastrointestinal symptoms; Bowel Habits - Bristol Stool Scale (BHD-BSS); Gastrointestinal Tolerance Questionnaire (GITQ); Acute; Biscuits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (40)

• Total Area Under the Curve of each individual gastrointestinal symptom

  tAUC between 0 and 24 hours

• Frequency of composite score > 1 at each time point

  Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

• Frequency of Diarrhea within 24 hours

  Evaluation performed over 24 hour after consumption of study products

• Time for maximum score for abdominal bloating

  Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

• Maximum score for abdominal bloating

  Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours

Study Arms (7)

Control biscuit

PLACEBO COMPARATOR

Sandwiched biscuit with usual sugar and fat content (2 servings = 60g)

Other: Control sandwiched biscuit with sugar

Control biscuit reduced in fat with EPG

ACTIVE COMPARATOR

Sandwiched biscuit with usual sugar content and fat partly replaced by EPG in basecake (2 servings = 60g)

Other: Test sandwiched biscuits with creme

Sugar reduced biscuit with blend 1

ACTIVE COMPARATOR

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 1 (2 servings = 60g)

Other: Test sandwiched biscuits with creme

Sugar reduced biscuit with blend 1 + EPG in basecake

ACTIVE COMPARATOR

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

Sugar reduced biscuit with blend 1 + EPG in basecake & creme

ACTIVE COMPARATOR

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

Sugar reduced biscuit with blend 2

ACTIVE COMPARATOR

Sandwiched biscuit reduced in sugar and containing sugar-replacer blend 2 (2 servings = 60g)

Other: Test sandwiched biscuits with creme

Sugar reduced biscuit with blend 2 + EPG in basecake

ACTIVE COMPARATOR

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

Interventions

Test sandwiched biscuits with creme OTHER

Acute intake

Control biscuit reduced in fat with EPG; Sugar reduced biscuit with blend 1; Sugar reduced biscuit with blend 1 + EPG in basecake; Sugar reduced biscuit with blend 1 + EPG in basecake & creme; Sugar reduced biscuit with blend 2; Sugar reduced biscuit with blend 2 + EPG in basecake

Control sandwiched biscuit with sugar OTHER

Acute intake

Control biscuit

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

Inquis Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Location

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The products will be labelled with a code, and participants will not be informed which test meal is which. Double 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. After the database has been created, cleaned, and locked a copy will be sent to the sponsor and then the codes will be broken.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In a 7-way cross-over, 14 sequences are required to obtain a balanced design. Orders will be assigned to participants in the order they attended for the first visit after being recruited. Four of these sequences will be separately randomized to create n=56 random sequences. If more subjects are recruited to replace drop-outs then the first new recruit will be assigned the sequence assigned the first drop-out, the second new recruit to sequence assigned to the second drop-out, etc.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: January 28, 2026
• Study Start: October 28, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)