Clinical trial NCT01775384: 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
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-induced Inflammation
Exercise-induced Oxidative Stress
Exercise-induced Immune Dysfunction
Keywords: Inflammation
Oxidative stress
Immune dysfunction
Metabolomics.
Lead sponsor: Appalachian State University
Sponsor class: OTHER
Collaborators: name: Dole Food Company
First posted: 2013-01-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Metabolomics; change in metabolites over time
timeFrame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Secondary outcomes:
measure: Change in inflammation
timeFrame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
measure: Change in oxidative stress
timeFrame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
measure: Change in immune function
timeFrame: 18-day period; Blood samples collected pre- and post-14 d supplementation, and immediately and 14 h after the third day of running
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: ASU Human Performance Laboratory, North Carolina Research Campus
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: David C Nieman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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.