The Anti-Inflammatory Effects of Exercise and Peanut Consumption

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 Overview

• Status: Terminated
• Conditions: Peanut Consumption; High Intensity Aerobic Exercise
• Intervention / Treatment: Other: High Intensity Interval Training; Other: Peanut Consumption

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Intensity Interval Training then Peanut Consumption; 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.	Other: High Intensity Interval Training; Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks; Other Names: Aerobic Exercise
EXPERIMENTAL: Peanut Consumption then High Intensity Interval Training; 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.	Other: Peanut Consumption; Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α)	cytokines (IL-6 and TNF-α) will be collected from blood samples	at study entry

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: Richard p Sloan, PhD, CUMC/NYSPI

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2017
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: exercise; heart rate variability; peanuts; nuts; vagal activity
• Other Study ID Numbers: #7466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: data will be made available in June 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No