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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Protein Diet | Experimental |
| |
| Standard Protein Diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Protein Diet | Behavioral | 16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight by weight scale | Participant body weights will be measured on a kg scale | Baseline to 16 weeks |
| Change in body weight by weight scale | Participant body weights will be measured on a kg scale | Baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Baseline to 52 weeks. |
| Change in % body fat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Hill, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Colorado Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37475689 | Derived | Clina JG, Sayer RD, Pan Z, Cohen CW, McDermott MT, Catenacci VA, Wyatt HR, Hill JO. High- and normal-protein diets improve body composition and glucose control in adults with type 2 diabetes: a randomized trial. Obesity (Silver Spring). 2023 Aug;31(8):2021-2030. doi: 10.1002/oby.23815. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Standard Protein Diet | Behavioral | 16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%. |
|
Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
| 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. | 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. | 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. | Baseline to 52 weeks. |
| Aurora |
| Colorado |
| 80045 |
| United States |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |