Effect of VLCD on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and NAFLD

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
NAFLD
Interventions
DIETARY_SUPPLEMENT

Dietary intervention with very low calorie diet (VLCD)

The VLCD program will last 8 weeks. The only sources of nutrition during this phase are the Optifast® products providing up to 800 kcal per day. Two liters (67.63 fl oz) of water should also be consumed each day. Participants will be instructed to use 5 replacement meals per day (800 kcal total) with 40% of calories as protein, 40% as carbohydrate, and 20% as fat.

OTHER

Control Arm

The control group will consume a lower calorie diet and will be instructed to reduce their usual intake of normally consumed foods by up to 500 kcal per day but no less than 1200 kcal per day.

Trial Locations (1)

52242

RECRUITING

University of Iowa Health Care, Iowa City

All Listed Sponsors
lead

University of Iowa

OTHER