Pistachios, Performance, Metabolomics

Inflammation Clinical Trial

Official title:

Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821820
• Other study ID #: 13-0064
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: January 30, 2015
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Appalachian State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immune Dysfunction
• Immune System Diseases
• Inflammation
• Oxidative Stress

Intervention

Other:
• Pistachios

Locations

Country	Name	City	State
United States	ASU Human Performance Laboratory, North Carolina Research Campus	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Appalachian State University	American Pistachio Growers

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shifts in metabolites (metabolomics)	Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.	14-day period	No
Secondary	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	14-day period	No
Secondary	Immune Function	Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential	14-day period	No
Secondary	Oxidative Stress	Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes	14-day period	No

External Links

•   Lab web site