NCT04138303

Exercise and Nutrition on Obese Microbiome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
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.
OTHER	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).
OTHER	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.

Timeline

• Start date: 2019-10-21
• Primary completion: 2019-12-21
• Completion: 2019-12-21
• First posted: 2019-10-24
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States