Actively Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Led by Arizona State University · Updated on 2026-05-08
114
Participants Needed
1
Research Sites
117 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
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
Official Title
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 50 years living in Phoenix, AZ, USA during the study
- Recreational competitive or non-competitive athletes exercising at least twice per week for a minimum of two hours per week
- Body mass index (BMI) between 18.5 and 30 kg/m2
- No physical limitations from injury and able to perform daily activities and exercise independently
- Willing to increase energy intake with a daily morning supplement before breakfast
- Comfortable performing multiple treadmill exercise tests during the study
- No contraindications according to the Physical Activity Readiness Questionnaire (PAR-Q+)
- Provide written informed consent
- For Part I: Self-perceived lactose intolerance, avoidance of dairy products, or identifying as Hispanic/Latino or Asian
- For Part I: Determined lactase non-persistent (LNP) CC genotype by genetic testing or positive lactose intolerance test (>20 ppm increase in hydrogen breath)
You will not qualify if you...
- Using probiotic or prebiotic supplements unwilling to stop for at least three weeks before the study
- Women planning to start or stop contraceptives before or during the study
- Women with severe additional gastrointestinal symptoms during their menstrual period
- Current smokers
- Diagnosed clinical lactose intolerance
- Clinical or self-perceived milk protein allergy
- Diagnosed gastrointestinal disorders or diseases
- Musculoskeletal disorders
- Diagnosed metabolic disorders such as diabetes
- Use of medications affecting protein metabolism (e.g., corticosteroids, NSAIDs, prescribed acne medications)
- Chronic use of gastric acid suppressants, anti-coagulants, or anti-inflammatory medications
- Use of antibiotics within the past six months
- Blood donation within the past two months
- Pregnant or lactating women
- Significant weight changes in the past four weeks due to illness or dietary restriction
- Athletes aiming to lose weight by reducing energy intake during the study
- For Part I: A hydrogen breath peak less than 20 ppm above baseline during lactose tolerance testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ASU Health Futures Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
Research Team
F
Floris C Wardenaar, PhD
CONTACT
K
Kinta Schott, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here