Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
NCT Number: NCT06479330
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Tolerance|Healthy Population
Interventions: OTHER: Milk Chocolate
Sponsor: Mondelēz International, Inc.
Collaborators: INQUIS Clinical Research
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-11-30
Locations: Inquis Clinical Research, Toronto, Ontario, Canada

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)

Primary Outcome Measures: 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 Outcome Measures: 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, 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), 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, Evaluation performed over 24 hour after consumption of study products|Time for maximum score for abdominal bloating, Time of the maximum score, 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|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|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