Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2022

Conditions
ObesityInsulin Resistance
Interventions
OTHER

Weight loss with very low fat plant-based diet and regular exercise

Participants will lose \~7-10% of their body weight while on a calorie-restricted very low fat plant-based (PB) diet and performing exercise 6 days/week (4 sessions/week under direct supervision). The macronutrient composition of the diet is approximately 70% of energy from carbohydrate, 15% from protein, and 15% from fat. Food will be provided in the form of take-out meals and will be picked up by participants during weekly study visits with a weight management dietitian. To promote adherence to the diet and exercise intervention, subjects will participate in a lifestyle intervention program that includes dietary and behavioral education topics. Treatment will be provided in weekly individual or group sessions depending on subject availability. (Note: this is the only intervention for the study; the hyperinsulinemic euglycemic clamp is not an intervention but is the gold standard for evaluating insulin sensitivity, a primary study outcome.)

Trial Locations (1)

63110

Washington University in St. Louis School of Medicine, St Louis

All Listed Sponsors
collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

lead

Washington University School of Medicine

OTHER

NCT02706288 - Effects of a Calorie Restricted, Very Low Fat Plant-based Diet and Multi-component Exercise Program on Metabolic Health | Biotech Hunter | Biotech Hunter