Digestive Health, Quality of Life
Conditions
Keywords
Participants, Healthy subjects, Athlete, Women, Men, Fermented Dairy, Prebiotics, Gut microbiota, Self-reported, GI tract, Diet, Sleep
Brief summary
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
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.
Interventions
OTHERfermented dairy protein with prebiotic fiber
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.
Sponsors
FrieslandCampina
Arizona State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Modifying diet by adding a fermented dairy protein with prebiotic fiber
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily self-reported digestive comfort | Study period covering day 1 to day 21 compared to day 22-42. | Daily variation of GI complaints (averaged itemized score 1-10) |
| Change in self-reported digestive comfort | Baseline (day 0), after 21 days and after 42 days. | Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chane in self-reported states of mood | Baseline (day 0), after 21 days and after 42 days. | Profile of Mood States (POMS) |
| Change in self-reported general wellbeing - Psychological Distress | Baseline (day 0), after 21 days and after 42 days. | Reported as psychological distress (mental distress, K6 scale - average score 0-24). |
| Change in participants microbiota composition of fecal samples | Baseline (day 0), after 21 days and after 42 days. | 16s microbial profiling |
| Change in self-reported general wellbeing - Physical Health | 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) |
| Change in dietary intake | Baseline (day 0), after 21 days and after 42 days. | 24-hour dietary recalls (food group intake, energy and macro- and micronutrient) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in food composition and diet quality | Baseline (day 0), after 21 days and after 42 days. | Rapid eating assessment in participants (REAP) |
| Change in product experience | Baseline (day 0), days 22, 23, 29, 36, 43. | Question about product experience (taste and concept liking) |
Countries
United States
Outcome results
None listed