Polyphenols, Exercise, and Metabolomics

Exercise-induced Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775384
• Other study ID #: 12-0134
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: January 22, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Appalachian State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Appalachian State University Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise-induced Immune Dysfunction
• Exercise-induced Inflammation
• Exercise-induced Oxidative Stress
• Immune System Diseases
• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	ASU Human Performance Laboratory, North Carolina Research Campus	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Appalachian State University	Dole Food Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Lab web site