Skip to main content
OpenTrials
Completed

NCT Number: NCT05303753

Protein-Prebiotic Wellbeing Study

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fermented dairy protein with prebiotic fiber

Other

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.

Primary outcomes

  1. Change in self-reported digestive comfort

    Time frame: Baseline (day 0), after 21 days and after 42 days.

    Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)

  2. Change in daily self-reported digestive comfort

    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)

Secondary outcomes

  1. Change in self-reported general wellbeing - Physical Health

    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)

  2. Change in self-reported general wellbeing - Psychological Distress

    Time frame: Baseline (day 0), after 21 days and after 42 days.

    Reported as psychological distress (mental distress, K6 scale - average score 0-24).

  3. Change in participants microbiota composition of fecal samples

    Time frame: Baseline (day 0), after 21 days and after 42 days.

    16s microbial profiling

  4. Change in dietary intake

    Time frame: Baseline (day 0), after 21 days and after 42 days.

    24-hour dietary recalls (food group intake, energy and macro- and micronutrient)

  5. Chane in self-reported states of mood

    Time frame: Baseline (day 0), after 21 days and after 42 days.

    Profile of Mood States (POMS)

Other outcomes

  1. Change in food composition and diet quality

    Time frame: Baseline (day 0), after 21 days and after 42 days.

    Rapid eating assessment in participants (REAP)

  2. Change in product experience

    Time frame: Baseline (day 0), days 22, 23, 29, 36, 43.

    Question about product experience (taste and concept liking)

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • FrieslandCampina

Registry information

Official study title

An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.