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| Name | Class |
|---|---|
| FrieslandCampina | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in food composition and diet quality | Rapid eating assessment in participants (REAP) | Baseline (day 0), after 21 days and after 42 days. |
| Change in product experience | Question about product experience (taste and concept liking) |
Inclusion Criteria:
Exclusion Criteria:
Participants can identify as: Male, Female, Non-binary/third gender, or as: Prefer not to say.
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| Name | Affiliation | Role |
|---|---|---|
| Floris Wardenaar, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Modifying diet by adding a fermented dairy protein with prebiotic fiber
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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. |
| Baseline (day 0), days 22, 23, 29, 36, 43. |
| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |