Exercise and Nutrition on Obese Microbiome

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138303
• Other study ID #: 20190936
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: December 21, 2019

Study information

• Verified date: January 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 21, 2019
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fecal microbiota diversity	Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation	Baseline, 9 weeks
Primary	Change in Bacteriodetes/Firmicutes ratio	Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation	Baseline, 9 weeks
Primary	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
Primary	Change in inflammatory markers	Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-a and liposaccharide (LPS) evaluated in pg/ml.	Baseline, 9 weeks
Primary	Change in leptin/adiponectin ratio	Change in serum adipose markers assessed as change in leptin/adiponectin ratio.	Baseline, 9 weeks
Primary	Correlation of serum triglycerides with leptin levels	The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.	Baseline, 9 weeks
Primary	Change in body weight	Change in body composition as evaluated as change in body weight measured in lbs.	Baseline, 9 weeks
Primary	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
Primary	Change in body composition	Change in body composition as evaluated as change in body fat and lean body mass percentage	Baseline, 9 weeks
Primary	Change in waist circumference	Change in waist circumference measured in inches.	Baseline, 9 weeks
Primary	Change in blood pressure	Change in blood pressure assessed as systolic and diastolic pressure in mmHg.	Baseline, 9 weeks
Primary	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