High Intensity Aerobic Exercise, Peanut Consumption
Conditions
Keywords
nuts, exercise, vagal activity, peanuts, heart rate variability
Brief 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. 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.
Interventions
OTHERHigh Intensity Interval Training
Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks
OTHERPeanut Consumption
Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Masking description
Data collection staff is masked
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA 1. Of either sex, 2. age 21-45 years 3. English-speaker 4. Overweight or obese 5. sedentary *
Exclusion criteria
1. Cardiovascular disease 2. 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. 3. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. Prostatic carcinoma will not be grounds for exclusion. 4. 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). 5. HIV infection 6. Pregnant or lactating (participation allowed 3 months after ceasing lactation). 7. Medications that alter inflammation or autonomic nervous system activity. 8. Any history of psychosis or ECT 9. Psychotic disorder (lifetime) 10. Current or recent (past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety disorder 11. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs. 12. Probiotic and dietary supplements that affect inflammation or the ANS 13. Physically active 14. Peanut allergy in subject or in family of subject. Subjects who are unsure of their allergy status will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α) | at study entry | cytokines (IL-6 and TNF-α) will be collected from blood samples |
Countries
United States
Participant flow
Recruitment details
Study terminated at early stage due to poor enrollment
Participants by arm
| Arm | Count |
|---|---|
| High Intensity Interval Training First Then Peanut Consumption High intensity interval training first then peanut consumption
High intensity interval training:
4 training sessions per week over a 4-week period, with 24hour rest-periods between each training day. Each session begins with a 3 min low intensity warm-up, and then participants exercise as rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the submaximal cardiopulmonary exercise testing. This 20 second period is followed by 40 seconds of low intensity exercise. | 2 |
| Peanut Consumption First Then High Intensity Interval Training Peanut consumption first then high intensity interval training
Peanut Consumption:
Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks. Daily caloric intake will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, and stress/activity factors. Peanuts replaces protein and fat containing foods so that the daily caloric intake will not differ from diet. To assess compliance, participants will be asked to bring back the empty, numbered peanut packets by the end of every week and will be given new packets weekly. Subjects will be informed that they will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they consumed their packets the previous day. | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Sequence (4 Weeks) | Lost to Follow-up | 1 | 0 |
| Second Sequence (4 Weeks) | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | High Intensity Interval Training First Then Peanut Consumption | Peanut Consumption First Then High Intensity Interval Training | Total |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 0 | 25 years STANDARD_DEVIATION 0 | 31.5 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α)
cytokines (IL-6 and TNF-α) will be collected from blood samples
Time frame: at study entry
Population: Study was terminated due to poor enrollment. No data was analyzed.