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Polyphenols, Exercise, and Metabolomics

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ClinicalTrials.gov Identifier: NCT01775384
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : January 25, 2013
Sponsor:
Collaborator:
Dole Food Company
Information provided by (Responsible Party):
Appalachian State University

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 25, 2013
Last Update Posted Date January 25, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polyphenols, Exercise, and Metabolomics
Official Title  ICMJE Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Exercise-induced Inflammation
  • Exercise-induced Oxidative Stress
  • Exercise-induced Immune Dysfunction
Intervention  ICMJE
  • Dietary Supplement: Nutrasorb
    from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Nutrasorb
    Soy protein powder sorbed with polyphenols from blueberries and green tea extract
    Intervention: Dietary Supplement: Nutrasorb
  • Placebo Comparator: Placebo
    Soy protein isolate powder without polyphenols (with food coloring)
    Intervention: Dietary Supplement: Placebo
Publications * Nieman DC, Gillitt ND, Knab AM, Shanely RA, Pappan KL, Jin F, Lila MA. Influence of a polyphenol-enriched protein powder on exercise-induced inflammation and oxidative stress in athletes: a randomized trial using a metabolomics approach. PLoS One. 2013 Aug 15;8(8):e72215. doi: 10.1371/journal.pone.0072215. eCollection 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775384
Other Study ID Numbers  ICMJE 12-0134
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Appalachian State University
Study Sponsor  ICMJE Appalachian State University
Collaborators  ICMJE Dole Food Company
Investigators  ICMJE
Principal Investigator: David C Nieman, DrPH Appalachian State University
PRS Account Appalachian State University
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP