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Pistachios, Performance, Metabolomics

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ClinicalTrials.gov Identifier: NCT01821820
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : February 2, 2015
Sponsor:
Collaborator:
American Pistachio Growers
Information provided by (Responsible Party):
Appalachian State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammation Oxidative Stress Immune Dysfunction Other: Pistachios Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

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.
Other: Pistachios
No Intervention: No pistachios
No pistachios for two weeks, or before and during 75 km cycling.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821820


Locations
United States, North Carolina
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28787
Sponsors and Collaborators
Appalachian State University
American Pistachio Growers
Investigators
Principal Investigator: David C. Nieman, DrPH Appalachian State University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT01821820     History of Changes
Other Study ID Numbers: 13-0064
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Keywords provided by Appalachian State University:
Inflammation
Oxidative stress
Immune dysfunction
Metabolites

Additional relevant MeSH terms:
Inflammation
Immune System Diseases
Pathologic Processes