Muscle SorenessNCT03698032
Effect of Pistachios on Muscle Recovery
A study testing Water, 1.5 oz Pistachios and 3.0 oz Pistachios in people with Muscle Soreness, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Water, 1.5 oz Pistachios and 3.0 oz Pistachios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 28 well-trained
- Competitive male athletes
- Must participate in at least 5 hours of vigorous exercise per week
- Must actively compete in sport.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182-7251
About this study
Official title: Pistachios as a Recovery Food Following Rigorous Exercise in Trained Athletes
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.
Read the 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.
- Conditions
- Muscle Soreness
- Being tested
- Water, 1.5 oz Pistachios, 3.0 oz Pistachios
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterDietary supplement
Participants will consume water only
1.5 oz PistachiosDietary supplement
Participants will consume water plus 1.5 oz of pistachios as the intervention
3.0 oz PistachiosDietary supplement
Participants will consume water plus 3.0 oz of pistachios as the intervention
| Study group | Role | What they receive |
|---|---|---|
| Water Arm | Active comparator | Participants will consume water only as the intervention Receives: Dietary Supplement: Water |
| 1.5 oz Pistachios | Active comparator | Participants will consume water plus 1.5 oz of pistachios as the intervention Receives: 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 Receives: Dietary Supplement: 3.0 oz Pistachios |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
For change in inflammatory response
Measured: Baseline and after two weeks of test food consumption
Change from baseline of body weight at two weeks
Measured: Baseline and after two weeks of test food consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start5 Feb 2019
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Kern, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698032
- Sponsor's protocol ID
- S00022068
- Status last verified
- May 2022
- First submitted
- 1 Oct 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36325128
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pistachios as a Recovery Food Following Rigorous Exercise in Trained Athletes
- ClinicalTrials.gov ID
- NCT03698032
- Acronym / sponsor ID
- S00022068
- Conditions
- Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water Arm | Active comparator | Dietary Supplement: WaterParticipants will consume water only as the intervention |
| 1.5 oz Pistachios | Active comparator | Dietary Supplement: 1.5 oz PistachiosParticipants will consume water plus 1.5 oz of pistachios as the intervention |
| 3.0 oz Pistachios | Active comparator | Dietary Supplement: 3.0 oz PistachiosParticipants will consume water plus 3.0 oz of pistachios as the intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 28 well-trained
- Competitive male athletes
- Must participate in at least 5 hours of vigorous exercise per week
- Must actively compete in sport.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterParticipants will consume water only | Dietary supplement | Water Arm |
| 1.5 oz PistachiosParticipants will consume water plus 1.5 oz of pistachios as the intervention | Dietary supplement | 1.5 oz Pistachios |
| 3.0 oz PistachiosParticipants will consume water plus 3.0 oz of pistachios as the intervention | Dietary supplement | 3.0 oz Pistachios |
Primary outcome
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
2 secondary outcomes
Change from baseline of serum c-reactive protein at two weeks
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 36325128Rayo 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.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Soreness
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
Estrogen Receptor-Positive Breast Carcinoma
Recruiting
Shower Gel and Participant-Reported Post-Exercise Soreness in Regular Exercisers
Post-Exercise Recovery, Muscle Soreness
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, 1.5 oz Pistachios and 3.0 oz Pistachios in people with Muscle Soreness, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03698032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.