Protein-Prebiotic Wellbeing Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Digestive Health, Quality of Life

Intervention / Treatment
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* Other: fermented dairy protein with prebiotic fiber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Modifying diet by adding a fermented dairy protein with prebiotic fiber
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single group<br>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. | Other: fermented dairy protein with prebiotic fiber<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported digestive comfort | Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores) | Baseline (day 0), after 21 days and after 42 days. | 
| Change in daily self-reported digestive comfort | Daily variation of GI complaints (averaged itemized score 1-10) | Study period covering day 1 to day 21 compared to day 22-42. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported general wellbeing - Physical Health | Reported as physical wellbeing (Physical Health Questionnaire, PHX - average score 1-7 based on 14 items) | Baseline (day 0), after 21 days and after 42 days. | 
| Change in self-reported general wellbeing - Psychological Distress | Reported as psychological distress (mental distress, K6 scale - average score 0-24). | Baseline (day 0), after 21 days and after 42 days. | 
| Change in participants microbiota composition of fecal samples | 16s microbial profiling | Baseline (day 0), after 21 days and after 42 days. | 
| Change in dietary intake | 24-hour dietary recalls (food group intake, energy and macro- and micronutrient) | Baseline (day 0), after 21 days and after 42 days. | 
| Chane in self-reported states of mood | Profile of Mood States (POMS) | Baseline (day 0), after 21 days and after 42 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Athlete, Participants, Healthy subjects, Women, Men, Fermented Dairy, Prebiotics, Gut microbiota, Self-reported, GI tract, Diet, Sleep