The Evidence of Optifast

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.

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

In both groups

150-180 minutes per week of moderate to vigorous intensity exercise
Group (weekly) and individual (per schedule) behavioral counseling sessions

(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 Phase

Conventional food, encouraged 1-2 meal replacements per day.

FOOD-BASED PROGRAM

(n=135 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 Phase

Increased energy intake to achieve weight maintenance.

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)

Patients experienced greater reductions in waist circumference using the OPTIFAST® program

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