RecruitingNot ApplicableNCT06946017

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

Effect of a Fermented Whey and Fiber Supplement on Digestive Comfort of Recreational Athletes With and Without GI Complaints


Sponsor

Arizona State University

Enrollment

114 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control placebo and Fermented dairy protein with prebiotic fiber supplement for people with digestive health and quality of life. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTFermented dairy protein with prebiotic fiber supplement

Both the intervention and placebo products contain a serving of 15g with \~53Kcal, 0.5g Fats, 5g Carbohydrate, 7.5g Protein that need to be dissolved as powder in water in a protein shaker that will be provided. The intervention product contains whey protein concentrate and a prebiotic fiber. All ingredients that are designated by the FDA as Generally Recognized as Safe (GRAS). Participants will be asked to take the supplement daily before breakfast.

DIETARY_SUPPLEMENTControl placebo

Both the intervention and placebo products contain a serving of 15g with \~53Kcal, 0.5g Fats, 5g Carbohydrate, 7.5g Protein that need to be dissolved as powder in water in a protein shaker that will be provided. The placebo product is calorically matched to the intervention product and the main ingredients are protein and carbohydrate. All ingredients that are designated by the FDA as Generally Recognized as Safe (GRAS). Participants will be asked to take the supplement daily before breakfast.


Locations(1)

ASU Health Futures Center

Phoenix, Arizona, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06946017


Related Trials