Polyphenols, Exercise, and Metabolomics

NCT01775384 — Not applicable, Completed, 34 participants, Appalachian State University

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

Registry	NCT01775384
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	34 (Actual)
Sponsor	Appalachian State University (Other); collaborators: Dole Food Company
Conditions	Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction
Interventions	Nutrasorb, Placebo (Dietary supplement)
Dates	start 2012-04-01, primary completion 2012-11-01, completion 2012-12-01, first posted 2013-01-25, last updated 2013-01-25
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Nutrasorb	Experimental	Dietary Supplement: Nutrasorb	Soy protein powder sorbed with polyphenols from blueberries and green tea extract
Placebo	Placebo comparator	Dietary Supplement: Placebo	Soy protein isolate powder without polyphenols (with food coloring)

Nutrasorb (Dietary supplement): from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)
Placebo (Dietary supplement)

+Outcome measures

Primary outcomes

Metabolomics; change in metabolites over time [18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running]: GC-MS and LC-MS through Metabolon

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
ASU Human Performance Laboratory, North Carolina Research Campus	Kannapolis, North Carolina	United States

+Publications

Results publication: Nieman DC, Gillitt ND, Knab AM, Shanely RA, Pappan KL, Jin F, Lila MA. Influence of a polyphenol-enriched protein powder on exercise-induced inflammation and oxidative stress in athletes: a randomized trial using a metabolomics approach. PLoS One. 2013 Aug 15;8(8):e72215. doi: 10.1371/journal.pone.0072215. eCollection 2013. PMID 23967286

+Investigators

David C Nieman, DrPH, Principal investigator, Appalachian State University