An interventional study of Low-sugar candies compared to regular sugar candies in Gastrointestinal Tolerance and Healthy Population, sponsored by Mondelēz International, Inc.. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Prevention
This study is a randomized, single-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of a sugar replacer blend (inulin + soluble corn fiber + erythritol) at 3 different doses
The study will have a randomized, single-blind, crossover design with 5 visits consisting of one screening visit and 4 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 3 test products made with the sugar replacer blend 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/discomfort, Gas/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 using the Bristol Stool Scale (BSS).
Exclusion Criteria:
Control chewable candy made with sugar and provided at a dose of 50 g (corresponding to 2 servings)
Other: Low-sugar candies compared to regular sugar candies
low-sugar chewable candy containing Soluble Corn Fiber + Inulin + Erythritol provided at a dose of 50 g (corresponding to 2 servings)
Other: Low-sugar candies compared to regular sugar candies
64% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings)
Other: Low-sugar candies compared to regular sugar candies
82% reduced sugar chewable candy containing Soluble Corn Fiber + Resistant wheat dextrins provided at a dose of 50 g (corresponding to 2 servings)
Other: Low-sugar candies compared to regular sugar candies
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. 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
Maximum score and time for maximum score for each gastrointestinal symptom
For each individual GI symptom: the proportion of participants reporting any (score\>0) or moderate/severe (score \>1) at each time point, the maximum detected score (which can range from 0 up to 3) and the 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 britol 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
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Mondelēz International, Inc.