The Anti-Inflammatory Effects of Exercise and Peanut Consumption

Peanut Consumption Clinical Trial

Official title:

The Anti-Inflammatory Effects of Exercise and Peanut Consumption

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03212144
• Other study ID #: #7466
• Status: Terminated
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• High Intensity Aerobic Exercise
• Peanut Consumption

Intervention

Other:
• High Intensity Interval Training
Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks
• Peanut Consumption
Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

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