Objective: To assess the efficacy and safety of a low calorie soy-based meal replacement program for the treatment of obesity.
Design: A 12-week prospective randomized controlled clinical trial.
Setting: Outpatient weight control research unit.
Subjects: One hundred obese (28<BMI<or=41 kg/m(2)) volunteers between the ages of 35 and 65 y. Seventy-four participants completed the trial.
Intervention: Participants were randomized to either the meal replacement treatment group (n=50; 240 g/day, 1200 kcal/day) or control group (n=50). Both groups at baseline received a single dietary counseling session and a pamphlet describing weight loss practices.
Main outcome measures: Weight, body fat, serum lipid concentrations.
Results: : By intent-to-treat analysis, the treatment group lost significantly more weight than the control group (7.00 vs 2.90 kg; P<0.001) and had a greater change in total (22.5 vs 6.8 mg/dl; P=0.013) and LDL cholesterol (21.2 vs 7.1 mg/dl; P<0.009). Among completers only, the treatment group again lost more weight (7.1 kg; n=37 vs 2.9 kg; n=37; P=0.0001) and had a greater reduction in total cholesterol (26.1 mg/dl; n=37 vs 6.7 mg/dl; P=0.0012) and a greater change in LDL cholesterol (21.6 vs 5.5 mg/dl; P=0.0025). (For any given degree of weight loss, the reduction in LDL cholesterol was significantly greater in the treatment group.) Treatment was well tolerated and no serious side effects were detected.
Conclusions: Use of this soy-based meal replacement formula was effective in lowering body weight, fat mass and in reducing LDL cholesterol beyond what could be expected given the weight lost.