Obesity Clinical Trial
Official title:
The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance.
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).
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