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OpenTrials
Completed

NCT Number: NCT01775384

Polyphenols, Exercise, and Metabolomics

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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Key information

Conditions

Exercise-induced Inflammation Exercise-induced Immune Dysfunction Exercise-induced Oxidative Stress Immune System Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrasorb

Dietary Supplement

from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)

Placebo

Dietary Supplement

Primary outcomes

  1. Metabolomics; change in metabolites over time

    Time frame: 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

  1. Change in inflammation

    Time frame: 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

  2. Change in oxidative stress

    Time frame: 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

  3. Change in immune function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Appalachian State University

Other

Collaborators

  • Dole Food Company

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2013
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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