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Polyphenols, Exercise, and Metabolomics

This study has been completed.
Sponsor:
Collaborator:
Dole Foods
Information provided by (Responsible Party):
Appalachian State University
ClinicalTrials.gov Identifier:
NCT01775384
First received: January 2, 2013
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Exercise-induced Inflammation
Exercise-induced Oxidative Stress
Exercise-induced Immune Dysfunction
 Dietary Supplement: Nutrasorb
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Appalachian State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    GC-MS and LC-MS through Metabolon


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    CRP and a cytokine panel

  • 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 ] [ Designated as safety issue: No ]
    F2-isoprostanes, protein carbonyls, FRAP, ORAC

  • 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 ] [ Designated as safety issue: No ]
    Anti-viral activity using virus-infected HeLa cells


Enrollment: 34
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775384

Locations
United States, North Carolina
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Appalachian State University
Dole Foods
Investigators
Principal Investigator: David C Nieman, DrPH Appalachian State University
  More Information

Additional Information:
Lab web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT01775384     History of Changes
Other Study ID Numbers: 12-0134
Study First Received: January 2, 2013
Last Updated: January 22, 2013
Health Authority: USA: Appalachian State University Institutional Review Board

Keywords provided by Appalachian State University:
Inflammation
Oxidative stress
Immune dysfunction
Metabolomics.

Additional relevant MeSH terms:
Immune System Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013