20
Participants
Start Date
October 1, 2023
Primary Completion Date
July 31, 2026
Study Completion Date
December 31, 2026
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.
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.
RECRUITING
University of Iowa Health Care, Iowa City
University of Iowa
OTHER