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Effect of Pistachios on Muscle Recovery

Primary Purpose

Muscle Soreness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water
1.5 oz Pistachios
3.0 oz Pistachios
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Soreness

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • San Diego State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Water Arm

1.5 oz Pistachios

3.0 oz Pistachios

Arm Description

Participants will consume water only as the intervention

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline of serum c-reactive protein at two weeks
For change in inflammatory response
Change from baseline of body weight at two weeks

Full Information

First Posted
October 1, 2018
Last Updated
May 3, 2022
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT03698032
Brief Title
Effect of Pistachios on Muscle Recovery
Official Title
Pistachios as a Recovery Food Following Rigorous Exercise in Trained Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Specific objectives are to determine the dose response to ingestion of pistachios for promotion of recovery from vigorous exercise. To accomplish this, investigators will examined whether regular consumption of pistachios followed by pistachio feeding at two different doses (1.5 and 3.0 oz) during the recovery period following eccentrically biased exercise (downhill running) promotes enhanced recovery as measured by muscle soreness, markers of muscle damage, and status for inflammation and oxidative stress in comparison to a control feeding of water in endurance-trained runners (18-35 years of age). Study Design A cross-over design performed in random order will be utilized in which participants will complete 3 trials separated by at least 3-4 weeks. At each testing site, 28 well-trained, competitive male athletes will be recruited. Participants will be required to participate in at least 5 hours of vigorous exercise per week and to actively compete in sport. Exclusion criteria include smoking, medications known to impact inflammation, musculoskeletal limitations and use of supplements known to impact antioxidant or inflammatory status within 1 month of participation. Approach/Methods Participants will consume water only, water plus 1.5 oz of pistachios, or water plus 3.0 oz of pistachios daily for 2 weeks during 3 separate trials in a randomized, cross-over fashion. Subjects will then report to the laboratory following an overnight fast and after abstaining from strenuous exercise for 2 days. Fasting blood samples will be collected and participants will complete a 40-min downhill run at -10% grade at 65-70% of a predetermined VO2max. A recovery serving of water or water along with one of the doses of pistachios will be provided. Antecubital blood samples will be collected before the bout of exercise and 24, 48, and 72 hours afterward. Muscle soreness will be assessed at each timepoint as well. Vertical jump will be assessed prior to the exercise bout and at each recovery timepoint. Daily consumption of the pistachios will continue during the 72-hour recovery period. All participants will receive individualized diet counseling by investigators on a biweekly basis. An initial 3-day food record will be analyzed using dietary software to serve as a starting point for which the diet counseling will be based. Each participant will be provided with an individualized plan outlining their required macronutrient and micronutrient intakes (including antioxidants) in grams corresponding to their habitual diet as determined by the 3-day diet diary. Once per week, participants will provide a 3-day food record to track compliance with the nutrition protocol. All participants will be provided with feedback in their next biweekly private counseling session. To ensure that the results were due, as much as possible, to the differing dietary intervention (pistachio ingestion), participants will be instructed not to take any vitamin or mineral supplements during the study. Data will be analyzed using a repeated measures ANOVA followed by paired T-tests as post-hoc tests using SPSS. Statistical significance will accepted at P<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Water Arm
Arm Type
Active Comparator
Arm Description
Participants will consume water only as the intervention
Arm Title
1.5 oz Pistachios
Arm Type
Active Comparator
Arm Description
Participants will consume water plus 1.5 oz of pistachios as the intervention
Arm Title
3.0 oz Pistachios
Arm Type
Active Comparator
Arm Description
Participants will consume water plus 3.0 oz of pistachios as the intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
Participants will consume water only
Intervention Type
Dietary Supplement
Intervention Name(s)
1.5 oz Pistachios
Intervention Description
Participants will consume water plus 1.5 oz of pistachios as the intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
3.0 oz Pistachios
Intervention Description
Participants will consume water plus 3.0 oz of pistachios as the intervention
Primary Outcome Measure Information:
Title
change from baseline of serum creatine kinase at 24, 48 and 72 hours
Description
Serum will be analyzed for concentrations of creatine kinase as marker of muscle damage
Time Frame
before the bout of exercise and 24, 48, and 72 hours afterward
Secondary Outcome Measure Information:
Title
Change from baseline of serum c-reactive protein at two weeks
Description
For change in inflammatory response
Time Frame
Baseline and after two weeks of test food consumption
Title
Change from baseline of body weight at two weeks
Time Frame
Baseline and after two weeks of test food consumption

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 28 well-trained Competitive male athletes Must participate in at least 5 hours of vigorous exercise per week Must actively compete in sport. Exclusion Criteria: 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
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182-7251
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36325128
Citation
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.
Results Reference
derived

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Effect of Pistachios on Muscle Recovery

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