Exercise and Nutrition on Obese Microbiome

University of Miami31 enrolled

Overview

The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Overweight and Obesity

Interventions

Exercise ProtocolOTHER

The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise. Exercises are performed in person as a group with other participating subjects and lead by certified instructors. Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.

Calorie-Restrictive Low Carbohydrate Diet (CR-LC)OTHER

Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. CR-LC consists of caloric and macronutrient restrictions. Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure. Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30). 2. Individuals who volunteer for the 54-day exercise program. 3. Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease. 4. Individuals who are not taking antibiotics and have not taken antibiotics within 3 months. 5. Individuals who are not taking probiotics. 6. Individuals who are not taking Metformin. 7. Individuals who are cleared by their physician to perform strenuous exercise. 8. Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed. 9. Individuals who are between 18 and 60. Exclusion criteria: 1\. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Change in fecal microbiota diversity

Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation

Time frame: Baseline, 9 weeks

Change in Bacteriodetes/Firmicutes ratio

Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation

Time frame: Baseline, 9 weeks

Percent change in fecal microbiota composition

Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation

Time frame: Baseline, 9 weeks

Change in inflammatory markers

Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.

Time frame: Baseline, 9 weeks

Change in leptin/adiponectin ratio

Change in serum adipose markers assessed as change in leptin/adiponectin ratio.

Time frame: Baseline, 9 weeks

Correlation of serum triglycerides with leptin levels

The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.

Time frame: Baseline, 9 weeks

Change in body weight

Change in body composition as evaluated as change in body weight measured in lbs.

Time frame: Baseline, 9 weeks

Change in resting metabolic rate

Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.

Data from ClinicalTrials.gov

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