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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Arizona State University
Study ID
NCT06946017
Status
Recruiting
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Conditions

  • Digestive Health
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Fermented dairy protein with prebiotic fiber supplement — DIETARY_SUPPLEMENT
    Both the intervention and placebo products contain a serving of 15g with \~53Kcal, 0.5g Fats, 5g Carbohydrate, 7.5g Protein that need to be dissolved as powder in water in a protein shaker that will be provided. The intervention product contains whey protein concentrate and a prebiotic fiber. All ingredients that are designated by the FDA as Generally Recognized as Safe (GRAS). Participants will be asked to take the supplement daily before breakfast.
  • Control placebo — DIETARY_SUPPLEMENT
    Both the intervention and placebo products contain a serving of 15g with \~53Kcal, 0.5g Fats, 5g Carbohydrate, 7.5g Protein that need to be dissolved as powder in water in a protein shaker that will be provided. The placebo product is calorically matched to the intervention product and the main ingredients are protein and carbohydrate. All ingredients that are designated by the FDA as Generally Recognized as Safe (GRAS). Participants will be asked to take the supplement daily before breakfast.

Study Details

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 Dates

Start date
Mar 31, 2025
Status verified
May 2026
Primary completion
Aug 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Fermented dairy protein with prebiotic fiber
    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).
  • Placebo Comparator: Control protein supplement
    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).

Primary Outcome Measure

Part I: Hydrogen in breath [ Time Frame: For 240 minutes post exercise after consuming a bolus of lactose. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ASU Health Futures CenterPhoenixArizona85054
Kinta Schott, MS
[email protected]
602-543-1853

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By research site
ASU Health Futures Center· Phoenix, AZ

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