We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Polyphenols, Exercise, and Metabolomics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775384
First Posted: January 25, 2013
Last Update Posted: January 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dole Food Company
Information provided by (Responsible Party):
Appalachian State University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Food Company
Investigators
Principal Investigator: David C Nieman, DrPH Appalachian State University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT01775384     History of Changes
Other Study ID Numbers: 12-0134
First Submitted: January 2, 2013
First Posted: January 25, 2013
Last Update Posted: January 25, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Inflammation
Immune System Diseases
Pathologic Processes