An interventional study of Milk Chocolate in Gastrointestinal Tolerance and Healthy Population, sponsored by Mondelēz International, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Prevention
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)
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).
Mondelēz International, Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Milk chocolate made with sugar at a dose of 45 g (2 servings)
Other: Milk Chocolate
Milk chocolate with maltitol replacing all sugar at a dose of 45 g (2 servings)
Other: Milk Chocolate
Milk chocolate with kestose oligofructose replacing all sugar at a dose of 45 g (2 servings)
Other: Milk 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
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
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).
Time frame: tAUC between 0 and 24 hours
Total Area Under the Curve of each individual gastrointestinal symptom
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
Time frame: tAUC between 0 and 24 hours
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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
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
Time frame: Evaluation performed over 24 hour after consumption of study products
Time for maximum score for abdominal bloating
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time of maximum score for abdominal pain
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for flatulence
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for burping
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for reflux
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for stomach rumbling
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for nausea
Time of the maximum score
Time frame: 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
Time frame: 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)
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Time for maximum score for vomiting
Time of the maximum score
Time frame: Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours
Number of bowel movements
Number of bowel movements over the 24 hours
Time frame: Evaluation performed over 24 hour after consumption of study products
straining during bowel movement
Proportion of participants having to strain or not
Time frame: Evaluation performed over 24 hour after consumption of study products
discomfort during bowel movement
Proportion of participants having discomfort or not
Time frame: Evaluation performed over 24 hour after consumption of study products
incomplete evacuation
Proportion of participants declaring incomplete evacuation or not
Time frame: Evaluation performed over 24 hour after consumption of study products
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.
Time frame: Evaluation performed over 24 hour after consumption of study products
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Oct 2024, 3 months.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Mondelēz International, Inc. →