- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821820
Pistachios, Performance, Metabolomics
January 30, 2015 updated by: Appalachian State University
Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.
Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling intensely for 75 kilometers will support substrate utilization during exercise (as determined through metabolomics) and improve performance compared to water only, and attenuate inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Kannapolis, North Carolina, United States, 28787
- ASU Human Performance Laboratory, North Carolina Research Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male endurance 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 cycling races.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pistachios
Pistachio treatment (3 oz/d) for two weeks; 3 oz pistachio nuts and water (1.5 oz.
before, and 1.5 oz during) cycling 75 km.
|
|
|
No Intervention: No pistachios
No pistachios for two weeks, or before and during 75 km cycling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shifts in metabolites (metabolomics)
Time Frame: 14-day period
|
Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.
|
14-day period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammation
Time Frame: 14-day period
|
Pre- and post-14 d supplementation, and following 75-km cycling; plasma IL-6, IL-8, IL-10, TNF-alpha, G-CSF, MCP-1; C-reactive protein
|
14-day period
|
|
Immune Function
Time Frame: 14-day period
|
Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential
|
14-day period
|
|
Oxidative Stress
Time Frame: 14-day period
|
Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes
|
14-day period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David C. Nieman, DrPH, Appalachian State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dreher ML. Pistachio nuts: composition and potential health benefits. Nutr Rev. 2012 Apr;70(4):234-40. doi: 10.1111/j.1753-4887.2011.00467.x.
- Nieman DC, Scherr J, Luo B, Meaney MP, Dreau D, Sha W, Dew DA, Henson DA, Pappan KL. Influence of pistachios on performance and exercise-induced inflammation, oxidative stress, immune dysfunction, and metabolite shifts in cyclists: a randomized, crossover trial. PLoS One. 2014 Nov 19;9(11):e113725. doi: 10.1371/journal.pone.0113725. eCollection 2014.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
March 27, 2013
First Submitted That Met QC Criteria
March 29, 2013
First Posted (Estimate)
April 1, 2013
Study Record Updates
Last Update Posted (Estimate)
February 2, 2015
Last Update Submitted That Met QC Criteria
January 30, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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