Pistachios, Performance, Metabolomics

This study is currently recruiting participants.
Verified December 2013 by Appalachian State University
Sponsor:
Collaborator:
American Pistachio Growers
Information provided by (Responsible Party):
Appalachian State University
ClinicalTrials.gov Identifier:
NCT01821820
First received: March 27, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention
Inflammation
Oxidative Stress
Immune Dysfunction
Other: Pistachios

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Appalachian State University:

Primary Outcome Measures:
  • Shifts in metabolites (metabolomics) [ Time Frame: 14-day period ] [ Designated as safety issue: No ]
    Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.


Secondary Outcome Measures:
  • Inflammation [ Time Frame: 14-day period ] [ Designated as safety issue: No ]
    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

  • Immune Function [ Time Frame: 14-day period ] [ Designated as safety issue: No ]
    Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential

  • Oxidative Stress [ Time Frame: 14-day period ] [ Designated as safety issue: No ]
    Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821820

Contacts
Contact: David C Nieman, DrPH 8287730056 niemandc@appstate.edu
Contact: Dustin Dew, MS 704-250-5359 dustindew@gmail.com

Locations
United States, North Carolina
ASU Human Performance Laboratory, North Carolina Research Campus Recruiting
Kannapolis, North Carolina, United States, 28787
Contact: David C Nieman, DrPH    828-773-0056    niemandc@appstate.edu   
Contact: Dustin Dew, MS    704-250-5359    dustindew@gmail.com   
Principal Investigator: David C Nieman, DrPH         
Sponsors and Collaborators
Appalachian State University
American Pistachio Growers
Investigators
Principal Investigator: David C. Nieman, DrPH Appalachian State University
  More Information

Additional Information:
Publications:
Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT01821820     History of Changes
Other Study ID Numbers: 13-0064
Study First Received: March 27, 2013
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Immune System Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014