NCT01821820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

March 27, 2013

Last Update Submit

January 30, 2015

Conditions

InflammationOxidative StressImmune Dysfunction

Keywords

InflammationOxidative stressImmune dysfunctionMetabolites

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Inflammation

    14-day period

  • Immune Function

    14-day period

  • Oxidative Stress

    14-day period

Study Arms (2)

Pistachios

EXPERIMENTAL

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 pistachios

NO INTERVENTION

No pistachios for two weeks, or before and during 75 km cycling.

Interventions

PistachiosOTHER
Pistachios

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, 28787, United States

Location

Related Publications (2)

  • 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.

    PMID: 22458696BACKGROUND

  • 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.

    PMID: 25409020DERIVED

Related Links

MeSH Terms

Conditions

InflammationImmune System Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David C. Nieman, DrPH

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 1, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

US(1)