Could a daily shake soothe Athletes' stomach troubles?
NCT ID NCT06946017
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a fermented whey protein and fiber supplement can improve digestive comfort in recreational athletes. Researchers will enroll 114 participants, some with and some without stomach complaints, and compare the supplement to a placebo. The goal is to see if it reduces gas, bloating, and other gut symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fermented whey protein concentrate with prebiotic fiber
- What this could lead to
- If it works, this could point toward a simple daily supplement to reduce stomach issues in athletes.
- What could go wrong
- This is an early-stage, small study (114 participants) testing a dietary supplement, not a drug. Results may not apply to non-athletes or those with serious digestive conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Aside from having participants fitting the inclusion and exclusion criteria below, potential participants will be screened using the gastrointestinal symptom rating scale (GSRS). Based on the outcome they will be assigned to the Part I (i.e. no self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with all items scored \<4 (severe) and a total GSRS score ≤25), or Part II (i.e. Severe self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with at least one item scored ≥4 (severe) and a total GSRS score ≥30). If they don't fit these criteria (i.e., having a GSRS score ranging from 26-29) they will be excluded from participation. Inclusion Criteria: * 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) Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASU Health Futures Center
RECRUITINGPhoenix, Arizona, 85054, United States
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