- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03698032
Effect of Pistachios on Muscle Recovery
Pistachios as a Recovery Food Following Rigorous Exercise in Trained Athletes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92182-7251
- San Diego State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Water Arm
Participants will consume water only as the intervention
|
Participants will consume water only
|
|
Active Comparator: 1.5 oz Pistachios
Participants will consume water plus 1.5 oz of pistachios as the intervention
|
Participants will consume water plus 1.5 oz of pistachios as the intervention
|
|
Active Comparator: 3.0 oz Pistachios
Participants will consume water plus 3.0 oz of pistachios as the intervention
|
Participants will consume water plus 3.0 oz of pistachios as the intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change from baseline of serum creatine kinase at 24, 48 and 72 hours
Time Frame: before the bout of exercise and 24, 48, and 72 hours afterward
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline of serum c-reactive protein at two weeks
Time Frame: Baseline and after two weeks of test food consumption
|
For change in inflammatory response
|
Baseline and after two weeks of test food consumption
|
|
Change from baseline of body weight at two weeks
Time Frame: Baseline and after two weeks of test food consumption
|
Baseline and after two weeks of test food consumption
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S00022068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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