Polyphenols, Exercise, and Metabolomics

Not Applicable

Completed

• Conditions: Exercise-induced Inflammation; Exercise-induced Oxidative Stress; Exercise-induced Immune Dysfunction
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Nutrasorb

• Registration Number: NCT01775384
• Lead Sponsor: Appalachian State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-22
• Last Update Submitted: 2013-01-22
• Study First Posted: 2013-01-25
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Soy protein isolate powder without polyphenols (with food coloring)
Nutrasorb	Nutrasorb	Soy protein powder sorbed with polyphenols from blueberries and green tea extract

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ASU Human Performance Laboratory, North Carolina Research Campus; 🇺🇸 Kannapolis, North Carolina, United States