Polyphenols, Exercise, and Metabolomics

January 22, 2013 updated by: Appalachian State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • ASU Human Performance Laboratory, North Carolina Research Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Appalachian State University

Collaborators

Dole Food Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 2, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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