This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
This study is a randomized, double-blind, crossover trial with 23 visits consisting of one screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of 2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy subjects will be randomized to a test sequence and will consume one control product and nine test products over the course of the study. Before consumption of any study products, breath hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be completed. Additionally, midway through the study, data will be reviewed in a blinded manner and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation tests. Gastrointestinal symptoms and stool information will be collected using the Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected throughout the day of study product consumption and the 2 days after product consumption. 24-h urine samples will be collected after study product consumption for urinary allulose analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
One pack of each product (1 to 10) will be consumed on a separate occasion
Biofortis Innovation Services
Addison, Illinois, United States
Difference in area under the curve (AUC) of the composite Gastrointestinal symptom score of each test product versus control
AUC of the composite Gastrointestinal symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Time frame: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC of the composite GI symptom score between doses within each formulation
Area under the curve (AUC) of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Time frame: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC of the composite GI symptom score between formulations within each dose
AUC of the composite GI symptoms score based on GITQ
Time frame: AUC between 0 to 48 hours after intake of products
Difference in the continuous AUC for each individual GI symptom score of test products as compared to control, dose within each formulation, and formulation within each dose
AUC of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Time frame: AUC between 0 to 48 hours after intake of products
Proportion of subjects who have a composite GI symptom score larger than 1 at each measured time point
AUC of the composite GI symptoms score based on GITQ (gastro-intestinal tolerance questionnaire)
Time frame: AUC between 0 to 48 hours after intake of products
Proportion of subjects with diarrhea based on BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
diarrhea
Time frame: Evaluation over 24 hours following intake of products
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Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) symptom at each measured time point for each individual outcome
Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire)
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Summary of the maximum detected score for each individual GI symptom
Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire)
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Summary of the time of the maximum detected score for each individual symptom
Individual GI symptoms from GITQ (gastro-intestinal tolerance questionnaire)
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Proportion of subjects that report any (score >0) or moderate-to-severe (score >1) bothersome loose stools on the GITQ at each measured time point
Loose stools from BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Time frame: Evaluation performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours
Difference between test and control products, between dose within each formulation, and between formulation within each dose for all parameters of the BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Bowel movment characteristics from BHD-BSS (Bowel Habit Diary - Brictol Stool Scale)
Time frame: At each bowel movement over 48 hours
Urinary allulose
Difference between test and control products, between dose (number of servings) within each formulation, and between formulation within each dose on urinary Allulose
Time frame: Collect over 24 hours
Gut Microbiota composition
Microbial composition by sequencing
Time frame: Baseline
Correlation analyses between microbiota composition and GITQ individual parameters
Mechanism of action
Time frame: AUC 0 to 48 hours for composite scores and evaluations performed at time 0, 120, 240, 360, 600 minutes and 24 and 48 hours