High Protein Diet
Behavioral16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
NCT Number: NCT03832933
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Alabama at Birmingham, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%.
Time frame: Baseline to 16 weeks
Participant body weights will be measured on a kg scale
Time frame: Baseline to 52 weeks
Participant body weights will be measured on a kg scale
Time frame: Baseline to 52 weeks.
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 16 weeks
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.
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.
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.
Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.
University of Alabama at Birmingham
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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