Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes

Conditions
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Diabetes Type 2, Obesity, Diet Modification

Intervention / Treatment
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* Behavioral: High Protein Diet
* Behavioral: Standard Protein Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age ≥18 years T2D diagnosis within previous 6 years (documented physician diagnosis, use of antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%) BMI of ≥27 kg/m2 Weight stable (±3kg in the last 3 months) Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months) medication dosage and not be planning to change medication dosage Willing and able to participate in a weekly group class for the first 16 weeks of the study, bi-weekly classes for the remainder of the study, and willing to participate in 4 study visits over the 52 week study period. Exclusion Criteria: HbA1c concentration of ≥12%. Pregnant or lactating within the past 6 months or trying to become pregnant. Individuals following a vegetarian/vegan only diet Food allergies (to red meats or other common protein sources) Using exogenous insulin for T2D management Taking other medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals that do not have a weight effect are allowed as long as use is continued without change during the study. Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included). Current Eating disorder (anorexia or bulimia) Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable. Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Protein Diet<br> | Behavioral: High Protein Diet<br>* 16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.<br>|
| Active Comparator: Standard Protein Diet<br> | Behavioral: Standard Protein Diet<br>* 16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, dietary protein