The Anti-Inflammatory Effects of Exercise and Peanut Consumption

NCT03212144 | Terminated Results

• 1 other identifier: #7466
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Peanut Consumption; High Intensity Aerobic Exercise

Keywords

nuts; exercise; vagal activity; peanuts; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Other: Peanut Consumption

Interventions

High Intensity Interval Training OTHER

Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks

Also known as: Aerobic Exercise

High Intensity Interval Training then Peanut Consumption

Peanut Consumption OTHER

Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.

Peanut Consumption then High Intensity Interval Training

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Of either sex,
• age 21-45 years
• English-speaker
• Overweight or obese
• sedentary

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Richard Sloan
• Organization: Columbia University

rps7@columbia.edu

6467748947

Study Officials

• Richard p Sloan, PhD

  CUMC/NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data collection staff is masked
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: July 11, 2017
• Study Start: August 20, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-03

Locations

US (1)