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

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).

Conditions

• Digestive Health
• Quality of Life

Interventions

DIETARY_SUPPLEMENT

Fermented 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_SUPPLEMENT

Control 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.

Sponsors & Collaborators

• Friesland Campina

  collaborator UNKNOWN

• Arizona State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2026-08-30

Completion

2027-06-30

Countries

• United States

Study Locations