Back to resultsExercise and Nutrition on Obese Microbiome
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Protocol
Calorie-Restrictive Low Carbohydrate Diet (CR-LC)
Ancestral Diet (AD)
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity
Eligibility Criteria
Inclusion criteria:
- Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
- Individuals who volunteer for the 54-day exercise program.
- Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
- Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
- Individuals who are not taking probiotics.
- Individuals who are not taking Metformin.
- Individuals who are cleared by their physician to perform strenuous exercise.
- Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
- 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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Exercise Only Group (EX)
Exercise with CR-LC Group
Exercise with Ancestral Diet (AD) Group
Arm Description
Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.
Participants will receive the exercise protocol and CR-LC Diet regimen.
Participants will receive the exercise protocol and AD regimen.
Outcomes
Primary Outcome Measures
Change in fecal microbiota diversity
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Change in Bacteriodetes/Firmicutes ratio
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
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
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.
Change in leptin/adiponectin ratio
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Correlation of serum triglycerides with leptin levels
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Change in body weight
Change in body composition as evaluated as change in body weight measured in lbs.
Change in resting metabolic rate
Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
Change in body composition
Change in body composition as evaluated as change in body fat and lean body mass percentage
Change in waist circumference
Change in waist circumference measured in inches.
Change in blood pressure
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04138303
Brief Title
Exercise and Nutrition on Obese Microbiome
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
December 21, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Only Group (EX)
Arm Type
Experimental
Arm Description
Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.
Arm Title
Exercise with CR-LC Group
Arm Type
Experimental
Arm Description
Participants will receive the exercise protocol and CR-LC Diet regimen.
Arm Title
Exercise with Ancestral Diet (AD) Group
Arm Type
Experimental
Arm Description
Participants will receive the exercise protocol and AD regimen.
Intervention Type
Other
Intervention Name(s)
Exercise Protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Calorie-Restrictive Low Carbohydrate Diet (CR-LC)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Ancestral Diet (AD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fecal microbiota diversity
Description
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Time Frame
Baseline, 9 weeks
Title
Change in Bacteriodetes/Firmicutes ratio
Description
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
Time Frame
Baseline, 9 weeks
Title
Percent change in fecal microbiota composition
Description
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
Title
Change in inflammatory markers
Description
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
Title
Change in leptin/adiponectin ratio
Description
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Time Frame
Baseline, 9 weeks
Title
Correlation of serum triglycerides with leptin levels
Description
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Time Frame
Baseline, 9 weeks
Title
Change in body weight
Description
Change in body composition as evaluated as change in body weight measured in lbs.
Time Frame
Baseline, 9 weeks
Title
Change in resting metabolic rate
Description
Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
Time Frame
Baseline, 9 weeks
Title
Change in body composition
Description
Change in body composition as evaluated as change in body fat and lean body mass percentage
Time Frame
Baseline, 9 weeks
Title
Change in waist circumference
Description
Change in waist circumference measured in inches.
Time Frame
Baseline, 9 weeks
Title
Change in blood pressure
Description
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
Time Frame
Baseline, 9 weeks
Title
Change in visceral fat
Description
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).
Time Frame
Baseline, 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
Individuals who volunteer for the 54-day exercise program.
Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
Individuals who are not taking probiotics.
Individuals who are not taking Metformin.
Individuals who are cleared by their physician to perform strenuous exercise.
Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Smith, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise and Nutrition on Obese Microbiome
We'll reach out to this number within 24 hrs