Polyphenols, Exercise, and Metabolomics

Study Overview
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Brief Summary
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Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both traditional and metabolomics-based outcome measures.

Official Title
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Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach

Conditions
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Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction

Intervention / Treatment
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* Dietary Supplement: Nutrasorb
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female endurance athletes; competitive runners or cyclists Capable of exercising for 2.5 h at a high intensity in the lab Ages 18-55 Agree to train normally and stay weight stable. Agree to avoid the use of large dose vitamin/mineral supplements Agree to avoid herbs and medications that influence inflammation Exclusion Criteria: Regularly take supplements or medicines known to effect inflammation. At moderate or high risk for cardiovascular disease. Younger than 18 or older than 55 years of age. No history of competing in long distance running and cycling races.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrasorb<br>Soy protein powder sorbed with polyphenols from blueberries and green tea extract | Dietary Supplement: Nutrasorb<br>* from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)<br>|
| Placebo Comparator: Placebo<br>Soy protein isolate powder without polyphenols (with food coloring) | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics; change in metabolites over time | GC-MS and LC-MS through Metabolon | 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammation | CRP and a cytokine panel | 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running | 
| Change in oxidative stress | F2-isoprostanes, protein carbonyls, FRAP, ORAC | 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running | 
| Change in immune function | Anti-viral activity using virus-infected HeLa cells | 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Oxidative stress, Immune dysfunction, Metabolomics.