Clinical trial NCT03212144: The Anti-Inflammatory Effects of Exercise and Peanut Consumption
Official title: The Anti-Inflammatory Effects of Exercise and Peanut Consumption
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peanut Consumption
High Intensity Aerobic Exercise
Keywords: nuts
exercise
vagal activity
peanuts
heart rate variability
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α)
timeFrame: at study entry
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: CUMC/NYSPI
name: Richard p Sloan, PhD
role: PRINCIPAL_INVESTIGATOR
References: