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THE OPTIWIN STUDY
OPTIWIN is a year-long study, designated to evaluate the effectiveness of the OPTIFAST® weight loss program, in comparison with a standard-of-care, reduced energy, food-base diet (modified version of Diabetes Prevention Program, DPP) and lifestyle intervention among adults with a BMI higher than 30.
Study Design
Duration
52 weeks: 26-week weight loss phase, followed by a 26-week weight maintenance phase.
How?
Open-label, randomized, controlled trial
Where?
multicenter (9 sites across the U.S.)
Participants
330 eligible for study; 273 in the mITT* study population
Method


(n=135 mITT*)
ACTIVE PHASE:
- Total meal replacement up to 16 weeks
- 800 kcal/day, based on BMI
- 40% carbohydrate, 40% protein, 20% fat
- Gradual introduction of food up to 26 weeks
MAINTENANCE:
Conventional food, encouraged 1-2 meal replacements per day.

FOOD-BASED PROGRAM
(n-=138 mITT*)
ACTIVE PHASE:
- Reduced energy (-500 to -750 kcal/day, 25% to 30% fat) diet based on *modified Diabetes Prevention Program for 26 weeks.
MAINTENANCE:
Increased energy intake to achieve weight maintenance.
IN BOTH GROUPS
150-180 minutes per week of moderate to vigorous intensity exercise
Group (weekly) and individual (per schedule) behavioral counseling sessions
Results
Mean weight loss (%)
Patients lost approximately 2x as much weight using the OPTIFAST® program
Mean change in total fat mass (kg)
OPTIFAST® program patients achieved greatest reductions in total fat mass
Mean change in waist circumference (cm)