The purpose of this study is to examine the impact of high protein (HP) vs. normal protein (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity guidance through a group-based weight loss program, State of Slim (SOS). The central hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain and 2) preferentially reducing fat mass while preserving FFM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Change in body weight by weight scale
Participant body weights will be measured on a kg scale
Time frame: Baseline to 16 weeks
Change in body weight by weight scale
Participant body weights will be measured on a kg scale
Time frame: Baseline to 52 weeks
Change in T2D diagnosis criteria
T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose \<126 mg/dL or hemoglobin A1c \<6.5%.
Time frame: Baseline to 52 weeks.
Change in % body fat
Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
Time frame: Baseline to 16 weeks
Change in % body fat
Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
Time frame: Baseline to 52 weeks.
Change in % fat free mass (FFM)
Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
Time frame: Baseline to 16 weeks.
Change in % FFM
Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
Time frame: Baseline to 52 weeks.
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