Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Insulin Resistance
  • Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Description

Reduced energy intake and increased physical activity have profound effects on cardiometabolic health as assessed by insulin sensitivity, ?-cell function, serum lipids, intra-abdominal fat mass, intrahepatic triglyceride content, and blood pressure, and is the cornerstone of treatment for people wit...

Reduced energy intake and increased physical activity have profound effects on cardiometabolic health as assessed by insulin sensitivity, ?-cell function, serum lipids, intra-abdominal fat mass, intrahepatic triglyceride content, and blood pressure, and is the cornerstone of treatment for people with obesity. However, the specific additional therapeutic effects of regular exercise in conjunction with diet-induced weight loss are not clear. In addition, the optimal dietary macronutrient composition needed to reduce cardiometabolic risk is not known. The use of a very low fat, plant-based (PB) diet is becoming increasingly popular to treat people with obesity and is the only diet therapy that is reimbursed by Medicare in the treatment of people with coronary heart disease. Participants will undergo nutritional counseling and have supervised exercise training 4 days per week until 7-10% weight loss is achieved. Meals will be provided and food diaries will be kept during weight loss. Tests before and after the intervention will include muscular strength and aerobic fitness, cardiovascular assessments, glucose tolerance tests, hyperinsulinemic euglycemic clamp test for insulin sensitivity, heavy water metabolism, resting energy expenditure/metabolic rate, muscle and fat biopsies, body composition scans, blood tests, and urine and stool collection. The overarching goal of this project is to conduct a comprehensive characterization of weight loss induced by using a PB diet with regular exercise in people with MAO, followed by a comparison of the effects of this study with those from another study that is evaluating the effect of the same amount of weight loss induced by using a PB diet alone, without exercise. Specifically, we will evaluate changes in body composition, body fat distribution, cardiopulmonary function, muscle strength, the plasma metabolome, insulin sensitivity, beta-cell function, systemic and adipose tissue inflammation and immune system function, adipose tissue and muscle cellular metabolic pathways, and the gut microbiome to determine cellular, multiorgan, and whole-body effects of PB diet alone and PB diet plus exercise. Accordingly, this study will fill two important gaps in our knowledge that have considerable physiological and clinical significance; the data from this study will provide: 1) a better understanding of the effects of a PB diet plus exercise on a series of key outcome measures, and 2) the potential additional benefit of adding regular exercise to a PB diet.

Tracking Information

NCT #
NCT02706288
Collaborators
Barnes-Jewish Hospital
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine