This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight loss program.
This study will compare two protein sources: proteins to include beef as the sole source of red meat compared to proteins excluding red meat within the context of an effective higher-protein weight loss and maintenance program derived from the Colorado Diet. All subjects will participate in a group-based program consisting of 16 weekly classes in 3-phases designed to produce weight loss and teach participants how to achieve a lifestyle to keep weight off permanently. All groups will be closed (same subjects, same leader) and will consist of 20 participants. Participants in both groups will receive instruction in cooking, recipes, and shopping instruction (using our grocery laboratory). This training will include strategies, tips and preparation techniques for preparing high protein meals according to their assigned groups. All subjects are given exercise plans and all subjects will receive memberships to the Anschutz Health and Wellness Center fitness center for the duration of the study. After completion of the 16-week program, subjects will be asked to follow the program on their own for an additional 2 months. This is a randomized study involving 120 study subjects (60 per arm). The investigators will compare the efficacy of inducing weight loss of two treatment arms derived from the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the higher-protein diet by participating in weekly group classes for the first four months of the study. There will be 6 classes of 20 subjects each (three classes for each treatment group). Subjects will be followed in the study for 6 months. Subjects will be randomized into one of two treatment groups as follows: * Group 1(SOS+B): Subjects will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado Diet as modified. The Colorado diet is a high protein (estimated 120-160g/day), low carb and low fat diet. Subjects will be directed and instructed to include beef as their sole source of red meat as a protein source during the study. Subjects will follow the diet protein guidelines, but will be directed and instructed to consume 4 or more servings of beef per week and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo and venison. Subjects will be advised to use the monetary stipends to purchase items from the lists of acceptable foods from the SOS book (to include beef products). Processed beef items will be allowed as identified by a list provided to the subjects. * Group 2 (SOS): Subjects will participate in a State of Slim class, receive the State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado diet as modified. Subjects will be directed and instructed to exclude beef and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo, and venison.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Subjects in the beef group will be asked to consume 4 or more servings of beef per week (and to avoid all other red meats) during the 6 month study.
Subjects in the non-beef group will be asked to avoid all red meats during the 6 month study.
University of Colorado Denver
Aurora, Colorado, United States
Change from baseline in % body weight at the end of a 16 week period and at the end of the 6 month period
Time frame: 16 weeks and 6 months
Change from baseline in % body fat at the end of a 16 week period
Time frame: 16 weeks
Change from baseline in lipid panel results at end of 16 week period and end of 6 month period
Time frame: 16 weeks and 6 months
Change from baseline in fasting blood glucose results at end of 16 week period and end of 6 month period.
Time frame: 16 weeks and 6 months
Change from baseline in hemoglobin A1C results at end of 16 week period and end of 6 month period.
Time frame: 16 weeks and 6 months
Differences in responses to study questionnaires between the two groups regarding satisfaction with the weight loss program.
Time frame: 6 months
Differences in responses to study questionnaires between the two groups regarding adherence to the weight loss program.
Time frame: 6 months
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