Exercise and Nutrition on Obese Microbiome

University of Miami

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: Ancestral Diet (AD); Other: Exercise Protocol; Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04138303

20190936

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups

Exercise Only Group (EX)

Experimental group

Description:

Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.

Treatment:

Other: Exercise Protocol

Exercise with CR-LC Group

Experimental group

Description:

Participants will receive the exercise protocol and CR-LC Diet regimen.

Treatment:

Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC)

Other: Exercise Protocol

Exercise with Ancestral Diet (AD) Group

Experimental group

Description:

Participants will receive the exercise protocol and AD regimen.

Treatment:

Other: Ancestral Diet (AD)

Other: Exercise Protocol