Clinical Trial

Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints

Recruiting
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-23.
Trial Details
NCT Number NCT06946017
Lead Sponsor Arizona State University
Collaborators: FrieslandCampina N.V.
Conditions Digestive Health, Quality of Life
Enrollment 114 participants
Start Date 2025-03-31
Primary Completion 2026-08-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-08