An interventional study of Beef group and Non-beef group in Weight Loss, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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:
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 120 is above the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
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Subjects in this group are asked to consume 4 or more servings of beef per week and to exclude all other red meats from their diet for the 6 month study.
Behavioral: Beef group
Subjects in this group are asked to avoid all red meats from their diet for the 6 month study.
Behavioral: Non-beef group
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.
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
Plan to share: No
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver