A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial.
OBJECTIVE
To assess the efficacy and safety of a low calorie soy-based meal replacement program for the treatment of obesity.


METHODS
A 12-week prospective randomized controlled clinical trial.


METHODS
Outpatient weight control research unit.


METHODS
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.


METHODS
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.


METHODS
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.
Allison
D B
DB
Department of Biostatistics and Center for Research on Clinical Nutrition, University of Alabama at Birmingham, Birmingham, Alabama 35294-0022, USA.
Gadbury
G
G
Schwartz
L G
LG
Murugesan
R
R
Kraker
J L
JL
Heshka
S
S
Fontaine
K R
KR
Heymsfield
S B
SB
D000328:Adult; D001794:Blood Pressure; D001824:Body Constitution; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004043:Dietary Fiber / Q000008:administration & dosage; D002149:Energy Intake; D005260:Female; D005526:Food, Formulated / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy* / Q000503:physiopathology; D030262:Soybean Proteins / Q000008:administration & dosage; D013025:Glycine max; D015431:Weight Loss
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004043:Dietary Fiber; D030262:Soybean Proteins; D002784:Cholesterol