Exercise and Nutrition on Obese Microbiome

The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program

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 Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Exercise Protocol; Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC); Other: Ancestral Diet (AD)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Only Group (EX); Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.	Other: Exercise Protocol; 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.
Experimental: Exercise with CR-LC Group; Participants will receive the exercise protocol and CR-LC Diet regimen.	Other: Exercise Protocol; 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.; Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC); 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).
Experimental: Exercise with Ancestral Diet (AD) Group; Participants will receive the exercise protocol and AD regimen.	Other: Exercise Protocol; 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.; Other: Ancestral Diet (AD); Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. AD consists of consuming only whole foods and avoiding processed foods. Emphasis will be on food quality with no caloric or macronutrient restrictions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal microbiota diversity	Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation	Baseline, 9 weeks
Change in Bacteriodetes/Firmicutes ratio	Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation	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	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.	Baseline, 9 weeks
Change in leptin/adiponectin ratio	Change in serum adipose markers assessed as change in leptin/adiponectin ratio.	Baseline, 9 weeks
Correlation of serum triglycerides with leptin levels	The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.	Baseline, 9 weeks
Change in body weight	Change in body composition as evaluated as change in body weight measured in lbs.	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.	Baseline, 9 weeks
Change in body composition	Change in body composition as evaluated as change in body fat and lean body mass percentage	Baseline, 9 weeks
Change in waist circumference	Change in waist circumference measured in inches.	Baseline, 9 weeks
Change in blood pressure	Change in blood pressure assessed as systolic and diastolic pressure in mmHg.	Baseline, 9 weeks
Change in visceral fat	Change in visceral fat levels will be measured using InBody570 with scores ranging from 1-20, with the higher score indicating increased visceral fat (worse outcome).	Baseline, 9 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Wesley Smith, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): December 21, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 20190936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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