Arizona State University
Phoenix, Arizona, 85004, United States
NCT Number: NCT05303753
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.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
A substantial number of athletes suffer from gastro-intestinal problems, which may impair performance and/or subsequent recovery. Also, gut barrier integrity is impaired with high-intensity training. Emerging studies are showing a positive correlation between the gut microbiome and muscle function, athletic performance, body composition, and natural energy levels. This study will perform an exploratory analysis of the well-being and digestive health of well-trained athletes, and assess the potential effect of fermented dairy protein with prebiotic fiber on these parameters.
Question 1: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber affect the self-reported digestive comfort compared to a 3-week baseline period? And additionally, will the quality of life (self-reported general well-being and states of mood) change with the use of this type of product?
Question 2: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber show an alteration in gut microbiota in comparison to a 3-week baseline period, while dietary intake remains unaffected?
Question 3: How is the 3-week supplementation of a fermented dairy protein with prebiotic fiber experienced by the participants (taste and concept liking)?
Question 4: Is there a difference in baseline gut microbiota between athletes with and athletes without self-reported GI complaints.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During the intervention period, the participant will consume a new product and will reduce the amount of protein in their normal diet reflecting the protein content of the new product.
Time frame: Baseline (day 0), after 21 days and after 42 days.
Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)
Time frame: Study period covering day 1 to day 21 compared to day 22-42.
Daily variation of GI complaints (averaged itemized score 1-10)
Time frame: Baseline (day 0), after 21 days and after 42 days.
Reported as physical wellbeing (Physical Health Questionnaire, PHX - average score 1-7 based on 14 items)
Time frame: Baseline (day 0), after 21 days and after 42 days.
Reported as psychological distress (mental distress, K6 scale - average score 0-24).
Time frame: Baseline (day 0), after 21 days and after 42 days.
16s microbial profiling
Time frame: Baseline (day 0), after 21 days and after 42 days.
24-hour dietary recalls (food group intake, energy and macro- and micronutrient)
Time frame: Baseline (day 0), after 21 days and after 42 days.
Profile of Mood States (POMS)
Time frame: Baseline (day 0), after 21 days and after 42 days.
Rapid eating assessment in participants (REAP)
Time frame: Baseline (day 0), days 22, 23, 29, 36, 43.
Question about product experience (taste and concept liking)
Arizona State University
Other
An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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