The purpose of this study is to determine the optimal dose of soluble fibers that induces tolerable gastrointestinal symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
138
2 sachets per day over 7-day challenge
2 sachets per day over 7-day challenge
CEN experimental
Dijon, France
RECRUITINGNon-tolerance
Percentage of non-tolerance events as defined by participant dropping out due to digestive symptoms during the 7-day intervention phase
Time frame: After 7 days of study product consumption
Score of the Digestive Symptoms Frequency Questionnaire (DSFQ)
The absolute change from baseline to day 7 of the intervention phase on the total score of the Digestive Symptoms Frequency Questionnaire (DSFQ)
Time frame: After 7 days of study product consumption
Visual Analog Scale (VAS) score
The absolute change of digestive symptoms from baseline to day 7 of the intervention phase on the daily Visual Analog Scale (VAS) score
Time frame: After 7 days of study product consumption
Maximum score of digestive symptoms
The maximum score of digestive symptoms from baseline to day 7 of the intervention phase using the daily Visual Analog Scale (VAS)
Time frame: After 7 days of study product consumption
The time to maximum score of digestive symptoms
The time to maximum score of digestive symptoms (Tmax) on the daily Visual Analog Scale (VAS) from baseline to day 7 of the intervention phase
Time frame: After 7 days of study product consumption
incremental Area Under Curve (iAUC)
The daily Visual Analog Scale (VAS) score incremental Area Under Curve (iAUC) from baseline to day 7 of the intervention phase
Time frame: After 7 days of study product consumption
Digestive Symptoms Frequency Questionnaire (DSFQ)
Danone Global Research & Innovation Center
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The absolute change from baseline to day 7 of the intervention phase on individual symptoms scores (4 symptoms sub-scores) of the Digestive Symptoms Frequency Questionnaire (DSFQ)
Time frame: After 7 days of study product consumption
Daily VAS at run-in phase
Time frame: After 7 days without product consumption
Stool Frequency Questionnaires (SFQ) at run-in phase
Time frame: After 7 days without product consumption
Bristol Stool Scale (BSS) at run-in phase
Time frame: After 7 days without product consumption
Food Frequency Questionnaire (FFQ) at V3
Time frame: After 7 days without product consumption
Nutrient daily intake and food group daily intake (MyFood24) at run-in phase
Time frame: After 7 days without product consumption
FODMAP daily content (Monash calculator) at run-in phase
Time frame: After 7 days without product consumption
DSFQ (total score and the 4 symptom sub-scores) at the run-in phase
Time frame: After 7 days without product consumption
Rome IV at V1 (IBS, FB, U-FBD, abdominal pain, bloating/distention at least once a week)
Time frame: At inclusion
Breath hydrogen concentration (ppm - OMED health device by Owlstone Medi-cal) from baseline (run-in) to day 7 of the intervention phase
Time frame: After 7 days of study product consumption
Breath methane concentration (ppm - OMED health device by Owlstone Medi-cal) from baseline (run-in) to day 7 of the intervention phase
Time frame: After 7 days of study product consumption
Association between breath hydrogen and methane concentrations and DSFQ score
Time frame: After 7 days of study product consumption
Association between breath hydrogen and methane concentrations and VAS score
Time frame: After 7 days of study product consumption