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Polyphenols, Exercise, and Metabolomics

Primary Purpose

Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrasorb
Placebo
Sponsored by
Appalachian State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise-induced Inflammation focused on measuring Inflammation, Oxidative stress, Immune dysfunction, Metabolomics.

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ASU Human Performance Laboratory, North Carolina Research Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutrasorb

Placebo

Arm Description

Soy protein powder sorbed with polyphenols from blueberries and green tea extract

Soy protein isolate powder without polyphenols (with food coloring)

Outcomes

Primary Outcome Measures

Metabolomics; change in metabolites over time
GC-MS and LC-MS through Metabolon

Secondary Outcome Measures

Change in inflammation
CRP and a cytokine panel
Change in oxidative stress
F2-isoprostanes, protein carbonyls, FRAP, ORAC
Change in immune function
Anti-viral activity using virus-infected HeLa cells

Full Information

First Posted
January 2, 2013
Last Updated
January 22, 2013
Sponsor
Appalachian State University
Collaborators
Dole Food Company
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1. Study Identification

Unique Protocol Identification Number
NCT01775384
Brief Title
Polyphenols, Exercise, and Metabolomics
Official Title
Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Appalachian State University
Collaborators
Dole Food Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Inflammation, Exercise-induced Oxidative Stress, Exercise-induced Immune Dysfunction
Keywords
Inflammation, Oxidative stress, Immune dysfunction, Metabolomics.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrasorb
Arm Type
Experimental
Arm Description
Soy protein powder sorbed with polyphenols from blueberries and green tea extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Soy protein isolate powder without polyphenols (with food coloring)
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrasorb
Intervention Description
from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Metabolomics; change in metabolites over time
Description
GC-MS and LC-MS through Metabolon
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
Secondary Outcome Measure Information:
Title
Change in inflammation
Description
CRP and a cytokine panel
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
Title
Change in oxidative stress
Description
F2-isoprostanes, protein carbonyls, FRAP, ORAC
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
Title
Change in immune function
Description
Anti-viral activity using virus-infected HeLa cells
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Nieman, DrPH
Organizational Affiliation
Appalachian State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASU Human Performance Laboratory, North Carolina Research Campus
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23967286
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncrc.appstate.edu
Description
Lab web site

Learn more about this trial

Polyphenols, Exercise, and Metabolomics

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