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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Digestive Health, Quality of Life

In brief

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).

Key facts

Study ID

NCT06946017

Run by

Arizona State University

People needed

114

Starts

2025-03-31

Expected to finish

2027-06-30

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects living in the Phoenix area in AZ, USA during the study
• Women/Men aged between 18-50 years (50-50%)
• Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours/week)
• BMI value between ≥18.5 and ≤ 30 kg/m2
• No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).
• Willing to slightly increase their energy intake via a supplement during the study period on daily basis in the morning before breakfast.
• Willing and comfortable to perform multiple physical (stress) tests on a treadmill during the study.
• Participants without any contraindications when scoring the Physical Activity Readiness Questionnaire (PAR-Q+).
• Written informed consent
• For part I: Self-perceived lactose intolerance, and/or omission of dairy products, and/or identifying as Hispanic/Latino or Asian
• For part I: Determined to be lactase non-persistent (LNP) CC genotype by qPCR, and/or positive lactose intolerance test (>20ppm increase from baseline when 25g of lactose administered)

You may not qualify if…

• Users of (sport) supplements containing probiotics and/or prebiotics and those unwilling to temporarily stop use of these supplements at least 3 weeks prior to start of the intervention
• Women who plan to start or stop the use of contraceptives before or during study period
• Women that have additional or worse GI symptoms during their period that can be classified as severe
• Smoking
• Clinical lactose intolerance
• Clinical or self-perceived milk protein allergy
• Diagnosed GI tract disorders or diseases
• Musculoskeletal disorders
• Diagnosed metabolic disorders (such as diabetes)
• Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
• Chronic use of gastric acid suppressing medication or anti-coagulants
• Chronic use of anti-inflammatory medication
• Use of antibiotics the past 0-6 months
• Blood donation in the past 2 months
• (Intending to become) Pregnant/lactating women
• Significant changes in body weight during the past 4 weeks (i.e., due to reduction of body weight through limiting caloric intake, illness,)
• Athletes should not aim to lose bodyweight by reducing energy intake during the study
• For Part I: A hydrogen breath peak of less than 20 ppm over baseline during a lactose tolerance test

Where it is running

• ASU Health Futures Center — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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