InflammationNCT01821820
Pistachios, Performance, Metabolomics
A study testing Pistachios in people with Inflammation and Oxidative Stress, run by Appalachian State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress, Immune Dysfunction
- What is being tested?
- Pistachios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2014
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, 28787
About this study
Official title: Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.
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.
- Conditions
- Inflammation, Oxidative Stress, Immune Dysfunction
- Being tested
- Pistachios
- Keywords
- Inflammation, Oxidative stress, Immune dysfunction, Metabolites
- Medical subject headings
- Inflammation, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PistachiosOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pistachios |
| No pistachios | No intervention | No pistachios for two weeks, or before and during 75 km cycling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shifts in metabolites (metabolomics)
Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.
Measured: 14-day period
Secondary outcomes (3)
Inflammation
Pre- and post-14 d supplementation, and following 75-km cycling; plasma IL-6, IL-8, IL-10, TNF-alpha, G-CSF, MCP-1; C-reactive protein
Measured: 14-day period
Immune Function
Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential
Measured: 14-day period
Oxidative Stress
Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes
Measured: 14-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pistachio Growers
- Responsible party
- Sponsor
- Investigators
- David C. Nieman, DrPH, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821820
- Sponsor's protocol ID
- 13-0064
- Status last verified
- Jan 2015
- First submitted
- 27 Mar 2013
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22458696Nieman 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.
PubMed 25409020
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.
- ClinicalTrials.gov ID
- NCT01821820
- Acronym / sponsor ID
- 13-0064
- Conditions
- Inflammation, Oxidative Stress, Immune Dysfunction
- Keywords
- Inflammation, Oxidative stress, Immune dysfunction, Metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- American Pistachio Growers
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Apr 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pistachios | Experimental | Other: PistachiosPistachio 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. |
| No pistachios | No intervention | –No pistachios for two weeks, or before and during 75 km cycling. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Pistachios | Other | Pistachios |
Primary outcome
Shifts in metabolites (metabolomics)
Time frame: 14-day period
Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.
3 secondary outcomes
Inflammation
Time frame: 14-day period
Immune Function
Time frame: 14-day period
Oxidative Stress
Time frame: 14-day period
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 2 Feb 2015.
- Background: PubMed 22458696Dreher 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.
- Derived from this study: PubMed 25409020Nieman 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.
- Lab web siteLink provided by the sponsor.
Related trials for Inflammation
Enrolling by invitationObservational study
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
Inflammation
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
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.
David C. Nieman, DrPH principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachios in people with Inflammation and Oxidative Stress, run by Appalachian 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 6 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 2 Feb 2015. 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?
Shifts in metabolites (metabolomics) (time frame: 14-day period). 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 NCT01821820, which also lists 2 linked publications.
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 2 Feb 2015.