Exercise and Nutrition on Obese Microbiome

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Other: Exercise Protocol; Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC); Other: Ancestral Diet (AD)

• Registration Number: NCT04138303
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-21
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Primary Completion: 2019-12-21
• Study Completion: 2019-12-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Only Group (EX)	Exercise Protocol	Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.
Exercise with Ancestral Diet (AD) Group	Exercise Protocol	Participants will receive the exercise protocol and AD regimen.
Exercise with CR-LC Group	Exercise Protocol	Participants will receive the exercise protocol and CR-LC Diet regimen.
Exercise with CR-LC Group	Calorie-Restrictive Low Carbohydrate Diet (CR-LC)	Participants will receive the exercise protocol and CR-LC Diet regimen.
Exercise with Ancestral Diet (AD) Group	Ancestral Diet (AD)	Participants will receive the exercise protocol and AD regimen.

Primary Outcome Measures

Name	Time	Method
Change in leptin/adiponectin ratio	Baseline, 9 weeks	Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Correlation of serum triglycerides with leptin levels	Baseline, 9 weeks	The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Change in Bacteriodetes/Firmicutes ratio	Baseline, 9 weeks	Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
Percent change in fecal microbiota composition	Baseline, 9 weeks	Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation
Change in body weight	Baseline, 9 weeks	Change in body composition as evaluated as change in body weight measured in lbs.
Change in waist circumference	Baseline, 9 weeks	Change in waist circumference measured in inches.
Change in fecal microbiota diversity	Baseline, 9 weeks	Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Change in resting metabolic rate	Baseline, 9 weeks	Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
Change in blood pressure	Baseline, 9 weeks	Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
Change in inflammatory markers	Baseline, 9 weeks	Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.
Change in visceral fat	Baseline, 9 weeks	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).
Change in body composition	Baseline, 9 weeks	Change in body composition as evaluated as change in body fat and lean body mass percentage

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States