Clinical trial · Interventional
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Effect of a Fermented Whey and Fiber Supplement on Digestive Comfort of Recreational Athletes With and Without GI Complaints
NCT06946017CI-TRIAL-00110899recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control placebo | Dietary Supplement | — | UNRESOLVED |
| Fermented dairy protein with prebiotic fiber supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fermented dairy protein with prebiotic fiber
- description
- During 3-week period participants consume a fermented dairy protein with prebiotic fiber. During Part I participants are randomly assigned to start with the experimental arm or the control arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial). During Part II participants are randomly assigned to the experimental arm only (double blind, randomized parallel trial).
- interventionNames
- Dietary Supplement: Fermented dairy protein with prebiotic fiber supplement
- type
- PLACEBO_COMPARATOR
- label
- Control protein supplement
- description
- During 3-week period participants consume a control supplement. During Part I participants are randomly assigned to start with the control arm or the experimental arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial). During Part II participants are randomly assigned to the control arm only (double blind, randomized parallel trial).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDWardenaar FC, Mohr AE, Ortega-Santos CP, Nyakayiru J, Kersch-Counet C, Chan Y, Clear AM, Kurka J, Schott KD, Seltzer RGN. 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. Nutrients. 2024 May 30;16(11):1712. doi: 10.3390/nu16111712. PMID 38892645