Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.
This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal of 60 study completers. Investigators will compare the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects each (two classes for each treatment group). Subjects will be followed in the study for 12 months. Subjects will be randomized into one of two treatment groups as follows: * Group 1 will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will then purchase food items allowed in the Colorado Diet from the lists of acceptable foods in the State of Slim book. * Group 2 will participate in a State of Slim class, receive the State of Slim book, and be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will receive up to 3 foods with approximately 20g of soy protein each, per day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
University of Colorado Denver, Anschutz Health and Wellness Center
Aurora, Colorado, United States
Change from baseline in % body weight at the end of a 16 week period
Time frame: at month 4
Change from baseline in body fat at the end of 16 week period
Time frame: at month 4
Change from baseline in % body weight at the end of a 52 week period
Time frame: at month 12
Change from baseline in body fat at the end of a 52 week period
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (total cholesterol)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (total cholesterol)
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (LDL)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (LDLl)
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (HDL)
Time frame: at month 4
Change from baseline in lipid panel results at end of 52 week period (HDL)
Time frame: at month 12
Change from baseline in lipid panel results at end of 16 week period (triglycerides)
Time frame: at month 4
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Change from baseline in lipid panel results at end of 52 week period (triglycerides)
Time frame: at month 12