Clinical trial · Interventional
Protein-Prebiotic Wellbeing Study
An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-week intervention period in which they maintain usage of their product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. In addition, a group of healthy participants without self-reported GI complaints will serve as a reference group by consuming the protein supplement that they normally use for recovery purposes after exercise during a 3-week period.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive Health | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fermented dairy protein with prebiotic fiber | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single group
- description
- During a 3-week baseline period, participants with self-reported GI complaints consume their own protein supplement that they use for recovery purposes after exercise, followed by a 3-week intervention period in which they maintain usage of their own product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. An additional reference group of athletes without self-reported GI complaints will also be followed during a 3-week period in which they consume their own protein supplement that they use for recovery purposes after exercise.
- interventionNames
- Other: fermented dairy protein with prebiotic fiber
Primary outcomes (2)
- measure
- Change in self-reported digestive comfort
- timeFrame
- Baseline (day 0), after 21 days and after 42 days.
- description
- Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy subjects living in Arizona in the USA * Women/Men aged between 18-35 years * Serious athletes (exercise at least 3 x per week) * With or without GI tract issues due to sport or protein/diet intake * 18.5 ≤ BMI ≤ 40 kg/m2 * No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner). * Use of a protein supplement or sports food after at least one training per day 3 x per week * Willing to slightly increase their protein supplement intake during the intervention phase for 21 consecutive days * Stable weight during the last 4 weeks, without a focus on body weight reduction through limiting caloric intake * Written informed consent Exclusion Criteria: * Daily use of (sport) supplements containing probiotics and/or prebiotics * Smoking * Self-reported cow's milk protein allergy * Clinical lactose intolerance * Clinical milk protein allergy * House dust mite allergy * Diagnosed GI tract disorders or diseases * Musculoskeletal disorders * 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 * Use of antibiotics or anti-inflammatory medication the past 2 weeks * Blood donation in the past 2 months * Pregnant/lactating women * Athletes should not aim to lose body weight by reducing energy intake during the study
References
Publications (0)
Data not yet available