NCT03698032

Brief Summary

Pistachios are an understudied and often unappreciated functional food. While nuts in general have received somewhat more attention for their nutritional properties from researchers, practitioners and the media, pistachios often seem to be overlooked. Meanwhile, pistachios appear to possess characteristics that suggest that they are likely to impart benefits that are equal to and perhaps above and beyond those of average nuts. We intend to explore the potential impacts of pistachios on recovery from rigorous exercise in well-trained athletes. We hypothesize that feeding 1.5 oz of pistachios will improve exercise recovery as determined by a reduction in delayed onset muscle soreness and suppression of markers of muscle damage, inflammation and oxidative stress in comparison to water and that the benefits will be greater with consumption of 3.0 oz of pistachios.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 5, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

October 1, 2018

Last Update Submit

May 3, 2022

Conditions

Muscle Soreness

Outcome Measures

Primary Outcomes (1)

  • change from baseline of serum creatine kinase at 24, 48 and 72 hours

    Serum will be analyzed for concentrations of creatine kinase as marker of muscle damage

    before the bout of exercise and 24, 48, and 72 hours afterward

Secondary Outcomes (2)

  • Change from baseline of serum c-reactive protein at two weeks

    Baseline and after two weeks of test food consumption

  • Change from baseline of body weight at two weeks

    Baseline and after two weeks of test food consumption

Study Arms (3)

Water Arm

ACTIVE COMPARATOR

Participants will consume water only as the intervention

Dietary Supplement: Water

1.5 oz Pistachios

ACTIVE COMPARATOR

Participants will consume water plus 1.5 oz of pistachios as the intervention

Dietary Supplement: 1.5 oz Pistachios

3.0 oz Pistachios

ACTIVE COMPARATOR

Participants will consume water plus 3.0 oz of pistachios as the intervention

Dietary Supplement: 3.0 oz Pistachios

Interventions

WaterDIETARY_SUPPLEMENT

Participants will consume water only

Water Arm
1.5 oz PistachiosDIETARY_SUPPLEMENT

Participants will consume water plus 1.5 oz of pistachios as the intervention

1.5 oz Pistachios
3.0 oz PistachiosDIETARY_SUPPLEMENT

Participants will consume water plus 3.0 oz of pistachios as the intervention

3.0 oz Pistachios

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • well-trained
  • Competitive male athletes
  • Must participate in at least 5 hours of vigorous exercise per week
  • Must actively compete in sport.

You may not qualify if:

  • Smoking
  • Medications known to impact inflammation
  • Medications known to impact musculoskeletal limitations
  • Use of supplements known to impact antioxidant or inflammatory status within 1 month of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182-7251, United States

Location

Related Publications (1)

  • Rayo VU, Thayer I, Galloway SDR, Hong MY, Hooshmand S, Liu C, North E, Okamoto L, O'Neal T, Philpott J, Witard OC, Kern M. Influence of pistachios on force production, subjective ratings of pain, and oxidative stress following exercise-induced muscle damage in moderately trained athletes: A randomized, crossover trial. Metabol Open. 2022 Oct 21;16:100215. doi: 10.1016/j.metop.2022.100215. eCollection 2022 Dec.

    PMID: 36325128DERIVED

MeSH Terms

Conditions

Myalgia

Interventions

Water

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 5, 2018

Study Start

February 5, 2019

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

US(1)