Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06946017

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

Led by Arizona State University · Updated on 2026-05-08

114

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

A

Arizona State University

Lead Sponsor

F

Friesland Campina

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of a fermented dairy protein with prebiotic fiber supplement on digestive health and well-being in recreational athletes who either have or do not have gastrointestinal (GI) complaints. This research includes two parts to evaluate how the supplement impacts GI symptoms, carbohydrate malabsorption, gut bacteria, immune markers, and overall gut health during exercise in warm conditions. The study is designed as a randomized, double-blind trial led by Arizona State University.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults aged 18 to 50 years living in Phoenix, AZ during the study
  • Recreational athletes exercising at least 2 times per week totaling minimum 2 hours weekly
  • Body mass index between 18.5 and 30 kg/m2
  • No physical limitations from injury that affect daily living or exercise
  • Willing to consume a daily supplement before breakfast during the study
  • Comfortable performing multiple treadmill exercise stress tests
  • No contraindications based on Physical Activity Readiness Questionnaire (PAR-Q+)
  • Provided written informed consent
  • For Part I: Self-perceived lactose intolerance, dairy avoidance, or identifying as Hispanic/Latino or Asian
  • For Part I: Lactase non-persistent genotype or positive lactose intolerance test
Not Eligible

You will not qualify if you...

  • Use of probiotic or prebiotic supplements unwilling to stop 3 weeks before intervention
  • Women planning to start or stop contraceptives before or during study
  • Women with severe GI symptoms worsening during menstrual periods
  • Smoking
  • Clinical lactose intolerance
  • Milk protein allergy (clinical or self-perceived)
  • Diagnosed gastrointestinal disorders or diseases
  • Musculoskeletal disorders
  • Diagnosed metabolic disorders such as diabetes
  • Use of medications affecting protein metabolism (e.g., corticosteroids, NSAIDs, acne meds)
  • Chronic use of gastric acid suppressing or anti-coagulant medication
  • Chronic use of anti-inflammatory medications
  • Antibiotic use in past 6 months
  • Blood donation in past 2 months
  • Pregnant or breastfeeding women
  • Recent significant weight changes or aiming to lose weight by reducing calorie intake
  • For Part I: Hydrogen breath peak less than 20 ppm over baseline during lactose test
  • Participants with moderate GSRS scores (between 26 and 29) are excluded from participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent, questionnaires, and exercise test

Familiarization Visit

Duration - 1 day

Participants undergo baseline measurements including body composition and a maximal exercise test to determine individual exercise intensity.

1 visit (in-person)

Treatment

Duration - 3 weeks per supplementation period

Participants consume a daily supplement of either fermented dairy protein with prebiotic fiber or a control protein supplement for 3 weeks during each intervention period.

Exercise testing days and fecal sample collection visits on Day 0, 21, 42, and 63 depending on study part and crossover schedule

Washout Period (Part I only)

Duration - 3 weeks

Participants have a 3-week break between supplementation periods to clear prior intervention effects.

No visits during this period

Exercise Testing and Assessments

Duration - Across treatment periods

Participants complete multiple 60-minute treadmill hiking exercise tests in a warm environment with measurements of digestive comfort, breath hydrogen, blood samples, and questionnaires before, during, and after exercise.

Multiple visits coinciding with supplementation days (e.g., Day 0, 21, 42, 63) with additional follow-up questionnaires the day after exercise tests

Trial Site Locations

Total: 1 location

1

ASU Health Futures Center

Phoenix, Arizona, United States, 85054

Actively Recruiting

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Research Team

F

Floris C Wardenaar, PhD

K

Kinta Schott, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Explorative Characterization of GI Complaints, General Physical and Mental Wellbeing, and Gut Microbiota in Trained Recreative and Competitive Athletes with or without Self-Reported Gastrointestinal Symptoms.

Floris C Wardenaar, Alex E Mohr, Carmen P Ortega-Santos...

https://pubmed.ncbi.nlm.nih.gov/38892645