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Recruiting
NCT06946017
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Conditions: Digestive Health, Quality of Life
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 114
Sponsor: Arizona State University
Location: ASU Health Futures Center Phoenix Arizona
Summary
A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections.
Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period).
Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).
Eligibility Criteria
Aside from having participants fitting the inclusion and exclusion criteria below, potential participants will be screened using the gastrointestinal symptom rating scale (GSRS). Based on the outcome they will be assigned to the Part I (i.e. no self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with all items scored \
Source: ClinicalTrials.gov (NCT06946017). StuddyBuddy aggregates publicly available trial information.