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Completed

NCT Number: NCT04138303

Exercise and Nutrition on Obese Microbiome

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.

Treatment and study plan

exercise protocol

Other

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)

Other

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)

Other

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 outcomes

  1. Change in fecal microbiota diversity

    Time frame: Baseline, 9 weeks

    Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation

  2. Change in Bacteriodetes/Firmicutes ratio

    Time frame: Baseline, 9 weeks

    Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation

  3. Percent change in fecal microbiota composition

    Time frame: Baseline, 9 weeks

    Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation

  4. Change in inflammatory markers

    Time frame: 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.

  5. Change in leptin/adiponectin ratio

    Time frame: Baseline, 9 weeks

    Change in serum adipose markers assessed as change in leptin/adiponectin ratio.

  6. Correlation of serum triglycerides with leptin levels

    Time frame: Baseline, 9 weeks

    The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.

  7. Change in body weight

    Time frame: Baseline, 9 weeks

    Change in body composition as evaluated as change in body weight measured in lbs.

  8. Change in resting metabolic rate

    Time frame: Baseline, 9 weeks

    Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.

  9. Change in body composition

    Time frame: Baseline, 9 weeks

    Change in body composition as evaluated as change in body fat and lean body mass percentage

  10. Change in waist circumference

    Time frame: Baseline, 9 weeks

    Change in waist circumference measured in inches.

  11. Change in blood pressure

    Time frame: Baseline, 9 weeks

    Change in blood pressure assessed as systolic and diastolic pressure in mmHg.

  12. Change in visceral fat

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2019
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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