Polyphenols, Exercise, and Metabolomics

NCT ID: NCT01775384

Last Updated: 2013-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nutrasorb

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

Group Type EXPERIMENTAL

Nutrasorb

Intervention Type DIETARY_SUPPLEMENT

from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)

Placebo

Soy protein isolate powder without polyphenols (with food coloring)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Nutrasorb

from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dole Food Company

INDUSTRY

Sponsor Role collaborator

Appalachian State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David C Nieman, DrPH

Role: PRINCIPAL_INVESTIGATOR

Appalachian State University

Locations

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ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23967286 (View on PubMed)

Related Links

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Other Identifiers

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12-0134

Identifier Type: -

Identifier Source: org_study_id

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