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Pistachios, Performance, Metabolomics

Primary Purpose

Inflammation, Oxidative Stress, Immune Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pistachios
Sponsored by
Appalachian State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Inflammation, Oxidative stress, Immune dysfunction, Metabolites

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • ASU Human Performance Laboratory, North Carolina Research Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pistachios

No pistachios

Arm Description

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 pistachios for two weeks, or before and during 75 km cycling.

Outcomes

Primary Outcome Measures

Shifts in metabolites (metabolomics)
Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.

Secondary Outcome Measures

Inflammation
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
Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential
Oxidative Stress
Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes

Full Information

First Posted
March 27, 2013
Last Updated
January 30, 2015
Sponsor
Appalachian State University
Collaborators
American Pistachio Growers
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1. Study Identification

Unique Protocol Identification Number
NCT01821820
Brief Title
Pistachios, Performance, Metabolomics
Official Title
Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Appalachian State University
Collaborators
American Pistachio Growers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Oxidative Stress, Immune Dysfunction
Keywords
Inflammation, Oxidative stress, Immune dysfunction, Metabolites

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pistachios
Arm Type
Experimental
Arm Description
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.
Arm Title
No pistachios
Arm Type
No Intervention
Arm Description
No pistachios for two weeks, or before and during 75 km cycling.
Intervention Type
Other
Intervention Name(s)
Pistachios
Primary Outcome Measure Information:
Title
Shifts in metabolites (metabolomics)
Description
Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.
Time Frame
14-day period
Secondary Outcome Measure Information:
Title
Inflammation
Description
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
Time Frame
14-day period
Title
Immune Function
Description
Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential
Time Frame
14-day period
Title
Oxidative Stress
Description
Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes
Time Frame
14-day period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Nieman, DrPH
Organizational Affiliation
Appalachian State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASU Human Performance Laboratory, North Carolina Research Campus
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28787
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22458696
Citation
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.
Results Reference
background
PubMed Identifier
25409020
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncrc.appstate.edu
Description
Lab web site

Learn more about this trial

Pistachios, Performance, Metabolomics

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