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

NCT06479330 | Completed

• 1 other identifier: KBE070 / INQ-2402
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Gastrointestinal Tolerance; Healthy Population

Keywords

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

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 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 Outcomes (32)

• 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 (5)

Control chocolate with sugar

PLACEBO COMPARATOR

Milk chocolate made with sugar at a dose of 45 g (2 servings)

Other: Milk Chocolate

Maltitol chocolate

ACTIVE COMPARATOR

Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings)

Other: Milk Chocolate

Kestose chocolate

ACTIVE COMPARATOR

Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings)

Other: Milk Chocolate

Kestose + cocoa and polydextrose premix dose 1 chocolate

ACTIVE COMPARATOR

Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 1 replacing all sugar at a dose of 45 g (2 servings)

Other: Milk Chocolate

Kestose + cocoa and polydextrose premix dose 2 chocolate

ACTIVE COMPARATOR

Millk chocolate with kestose oligofructose + cocoa and polydextrose premix dose 2 replacing all sugar at a dose of 45 g (2 servings)

Other: Milk Chocolate

Interventions

Milk Chocolate OTHER

Acute intake

Control chocolate with sugar; Kestose + cocoa and polydextrose premix dose 1 chocolate; Kestose + cocoa and polydextrose premix dose 2 chocolate; Kestose chocolate; Maltitol chocolate

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, Canada

Location

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 so study staff and research participants will be blinded as to which test meal is which. After the database will be cleaned and locked, and statistical analysis will be completed, and the codes will be broken.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 28, 2024
• Study Start: July 9, 2024
• Primary Completion: October 16, 2024
• Study Completion: December 20, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)