Peanut ConsumptionNCT03212144
The Anti-Inflammatory Effects of Exercise and Peanut Consumption
A study testing High Intensity Interval Training and Peanut Consumption in people with Peanut Consumption and High Intensity Aerobic Exercise, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Consumption, High Intensity Aerobic Exercise
- What is being tested?
- High Intensity Interval Training and Peanut Consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Of either sex,
- age 21-45 years
- English-speaker
- Overweight or obese
- sedentary
Who cannot join
- Cardiovascular disease
- Uncontrolled high blood pressure (blood pressure ≥ 140/90). Individuals with controlled hypertension (i.e. under medical treatment) and blood pressure lower than 140/90 will not be excluded.
- Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. Prostatic carcinoma will not be grounds for exclusion.
- Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II).
- HIV infection
- Pregnant or lactating (participation allowed 3 months after ceasing lactation).
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- Medications that alter inflammation or autonomic nervous system activity.
- Any history of psychosis or ECT
- Psychotic disorder (lifetime)
- Current or recent (past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety disorder
- Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
- Probiotic and dietary supplements that affect inflammation or the ANS
- Physically active
- Peanut allergy in subject or in family of subject. Subjects who are unsure of their allergy status will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. The study will test and compare the effect of peanuts and exercise on inflammation and heart rate variability as indicators of heart health. Specifically, the study will measure inflammation in the blood because there is evidence that higher inflammation is found in heart disease patients. There is also evidence that inflammation is related to death as a result of heart disease in healthy individuals. Finally, there are ongoing trials targeting these markers to improve heart health. The study hypothesizes that peanuts and exercise will reduce inflammation. It is also expected to find less inflammation because exercise and peanut consumption activate a part of the nervous system that has been shown to cause a similar effect.
Additionally, previous studies show that inflammation involves the mitochondria in the cell, the part of the cell that produces energy. For this reason, it is expected that exercise and peanuts will cause changes in the mitochondria. The study will test and compare mitochondrial activity in response to peanut consumption and exercise.
- Being tested
- High Intensity Interval Training, Peanut Consumption
- Keywords
- nuts, exercise, vagal activity, peanuts, heart rate variability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
Also called Aerobic Exercise
Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks
Peanut ConsumptionOther
Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training then Peanut Consumption | Experimental | Exercise group: 4 training sessions/week, 24 hour rest-periods between each training day. 3-min low intensity warm-up, and then exercise as rapidly as possible for 20 seconds, aiming to reach 85% of their maximum heart rate established during the submaximal cardiopulmonary exercise testing. Then followed by 40 seconds of low intensity exercise. Peanut group: Regular daily caloric intake estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice a day, range from approximately 2.4-3.6 ounces. Daily caloric intake will not differ from participants' typical diet. Participants are asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they will be randomly assessed weekly for compliance. Receives: Other: High Intensity Interval Training |
| Peanut Consumption then High Intensity Interval Training | Experimental | Exercise group: 4 training sessions/week, 24 hour rest-periods between each training day. 3-min low intensity warm-up, and then exercise as rapidly as possible for 20 seconds, aiming to reach 85% of their maximum heart rate established during the submaximal cardiopulmonary exercise testing. Then followed by 40 seconds of low intensity exercise. Peanut group: Regular daily caloric intake estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice a day, range from approximately 2.4-3.6 ounces. Daily caloric intake will not differ from participants' typical diet. Participants are asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they will be randomly assessed weekly for compliance. Receives: Other: Peanut Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α)
cytokines (IL-6 and TNF-α) will be collected from blood samples
Measured: at study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start20 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peanut ConsumptionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Sloan, New York State Psychiatric Institute
- Investigators
- Richard p Sloan, PhD, Principal investigator, CUMC/NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212144
- Sponsor's protocol ID
- #7466
- Status last verified
- Mar 2020
- First submitted
- 8 Jun 2017
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be made available in June 2018
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anti-Inflammatory Effects of Exercise and Peanut Consumption
- ClinicalTrials.gov ID
- NCT03212144
- Acronym / sponsor ID
- #7466
- Keywords
- nuts, exercise, vagal activity, peanuts, heart rate variability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 6 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. Participants will either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity intervals (HIIT) for 4 weeks, or the reverse order. The study will test and compare the effect of peanuts and exercise on inflammation and heart rate variability as indicators of heart health. Specifically, the study will measure inflammation in the blood because there is evidence that higher inflammation is found in heart disease patients. There is also evidence that inflammation is related to death as a result of heart disease in healthy individuals. Finally, there are ongoing trials targeting these markers to improve heart health. The study hypothesizes that peanuts and exercise will reduce inflammation. It is also expected to find less inflammation because exercise and peanut consumption activate a part of the nervous system that has been shown to cause a similar effect.
Additionally, previous studies show that inflammation involves the mitochondria in the cell, the part of the cell that produces energy. For this reason, it is expected that exercise and peanuts will cause changes in the mitochondria. The study will test and compare mitochondrial activity in response to peanut consumption and exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training then Peanut Consumption | Experimental | Other: High Intensity Interval TrainingExercise group: 4 training sessions/week, 24 hour rest-periods between each training day. 3-min low intensity warm-up, and then exercise as rapidly as possible for 20 seconds, aiming to reach 85% of their maximum heart rate established during the submaximal cardiopulmonary exercise testing. Then followed by 40 seconds of low intensity exercise. Peanut group: Regular daily caloric intake estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice a day, range from approximately 2.4-3.6 ounces. Daily caloric intake will not differ from participants' typical diet. Participants are asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they will be randomly assessed weekly for compliance. |
| Peanut Consumption then High Intensity Interval Training | Experimental | Other: Peanut ConsumptionExercise group: 4 training sessions/week, 24 hour rest-periods between each training day. 3-min low intensity warm-up, and then exercise as rapidly as possible for 20 seconds, aiming to reach 85% of their maximum heart rate established during the submaximal cardiopulmonary exercise testing. Then followed by 40 seconds of low intensity exercise. Peanut group: Regular daily caloric intake estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Participants consume dry roasted, unsalted peanuts equivalent to approximately 10% of daily energy intake twice a day, range from approximately 2.4-3.6 ounces. Daily caloric intake will not differ from participants' typical diet. Participants are asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they will be randomly assessed weekly for compliance. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (14 listed)
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 |
|---|---|---|
| High Intensity Interval TrainingAlso: Aerobic ExerciseSubjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks | Other | High Intensity Interval Training then Peanut Consumption |
| Peanut ConsumptionSubjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. | Other | Peanut Consumption then High Intensity Interval Training |
Primary outcome
Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α)
Time frame: at study entry
cytokines (IL-6 and TNF-α) will be collected from blood samples
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. data will be made available in June 2018
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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.
Richard p Sloan, PhD principal investigator
CUMC/NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Peanut Consumption in people with Peanut Consumption and High Intensity Aerobic Exercise, run by New York State Psychiatric Institute 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 6 Apr 2020. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α) (time frame: at study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.