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Polyphenols, Exercise, and Metabolomics

Influence of a Polyphenol-enriched Protein Powder on Exercise-induced Inflammation and Oxidative Stress in Athletes: a Metabolomics Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01775384
Enrollment
34
Registered
2013-01-25
Start date
2012-04-30
Completion date
2012-12-31
Last updated
2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Inflammation, Oxidative stress, Immune dysfunction, Metabolomics.

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.

Interventions

DIETARY_SUPPLEMENTNutrasorb

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

DIETARY_SUPPLEMENTPlacebo

Sponsors

Dole Food Company
CollaboratorINDUSTRY
Appalachian State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Metabolomics; change in metabolites over time18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of runningGC-MS and LC-MS through Metabolon

Secondary

MeasureTime frameDescription
Change in inflammation18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of runningCRP and a cytokine panel
Change in oxidative stress18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of runningF2-isoprostanes, protein carbonyls, FRAP, ORAC
Change in immune function18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of runningAnti-viral activity using virus-infected HeLa cells

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026