Peanut Consumption Clinical Trial
Official title:
The Anti-Inflammatory Effects of Exercise and Peanut Consumption
| Verified date | March 2020 |
| Source | New York State Psychiatric Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 45 Years |
| Eligibility |
- 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Columbia University Medical Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| New York State Psychiatric Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-a) | cytokines (IL-6 and TNF-a) will be collected from blood samples | at study entry |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05932875 -
Peanut Consumption to Augment Adaptations to Concurrent Resistance and Aerobic Exercise Training
|
N/A |