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

March 26, 2026 updated by: Mondelēz International, Inc.
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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Inquis Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control chocolate with sugar
Milk chocolate made with sugar at a dose of 45 g (2 servings)
Other: Milk Chocolate
Acute intake
Active Comparator: Maltitol chocolate
Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings)
Other: Milk Chocolate
Acute intake
Active Comparator: Kestose chocolate
Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings)
Other: Milk Chocolate
Acute intake
Active Comparator: Kestose + cocoa and polydextrose premix dose 1 chocolate
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
Acute intake
Active Comparator: Kestose + cocoa and polydextrose premix dose 2 chocolate
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
Acute intake

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
Time Frame: tAUC between 0 and 24 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Diarrhea within 24 hours
Time Frame: Evaluation performed over 24 hour after consumption of study products
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
Time Frame: Evaluation performed over 24 hour after consumption of study products
Number of bowel movements over the 24 hours
Evaluation performed over 24 hour after consumption of study products
straining during bowel movement
Time Frame: Evaluation performed over 24 hour after consumption of study products
Proportion of participants having to strain or not
Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement
Time Frame: Evaluation performed over 24 hour after consumption of study products
Proportion of participants having discomfort or not
Evaluation performed over 24 hour after consumption of study products
incomplete evacuation
Time Frame: Evaluation performed over 24 hour after consumption of study products
Proportion of participants declaring incomplete evacuation or not
Evaluation performed over 24 hour after consumption of study products
Total Area Under the Curve of each individual gastrointestinal symptom
Time Frame: tAUC between 0 and 24 hours
Total Area Under the Curve of each of the individual 8 gastrointestinal symptoms (abdominal bloating, abdominal pain, flatulence, burping, reflux, stomach rumbling, nausea, vomiting). 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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time for maximum score for abdominal bloating
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for abdominal bloating
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for flatulence
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for burping
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for reflux
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for stomach rumbling
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for nausea
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Maximum score for vomiting
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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 Frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of the maximum score
Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Stool consistency based on bristol stool scale
Time Frame: Evaluation performed over 24 hour after consumption of study products
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mondelēz International, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
INQUIS Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KBE070 / INQ-2402

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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