Original Communication

European Journal of Clinical Nutrition (2003) 57, 514–522. doi:10.1038/sj.ejcn.1601587

A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial

D B Allison1, G Gadbury3, L G Schwartz2, R Murugesan2, J L Kraker2, S Heshka2, K R Fontaine4 and S B Heymsfield2

  1. 1Department of Biostatistics and Center for Research on Clinical Nutrition, University of Alabama at Birmingham, Birmingham, Alabama, USA
  2. 2Obesity Research Center, St. Luke's/Roosevelt Hospital, Institute of Human Nutrition Columbia University College of Physicians and Surgeons, New York, USA
  3. 3Department of Mathematics and Statistics, University of Missouri at Rolla, Rolla, Missouri, USA
  4. 4Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

Correspondence: D B Allison, Department of Biostatistics, Ryals Public Health Bldg 327, 1665 University Blvd, University of Alabama at Birmingham, Birmingham, AL 35294-0022, USA. E-mail: dallison@.uab.edu

Guarantor: DB Allison.

Contributors: DBA was involved in the design, oversight, analysis, and the drafting of the manuscript. GG assisted in the data analysis and the drafting of the manuscript. LGS and RM were involved in the execution of the study and data interpretation. JLK conducted preliminary data analysis and assisted in the drafting of the manuscript. KRF assisted with manuscript preparation, the interpretation of the data, and editing. SH and SBH were involved in the design and oversight of the study, as well as editing drafts of the manuscript.

Received 28 February 2002; Revised 20 June 2002; Accepted 26 June 2002.

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Abstract

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<BMIless than or equal to41 kg/m2) volunteers between the ages of 35 and 65 y. Seventy-four participants completed the trial.

Interventions: 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.

Sponsorship: This research was funded by Nutripharma. Dr Allison is a member of the United Soybean Board's Scientific Advisory Panel and Chair of the Research Grants Committee.

Keywords:

obesity, soy, randomized controlled clinical trial, cholesterol

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