Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 4
- 主要终点
- Change in body weight by weight scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in body weight by weight scale
时间窗: Baseline to 52 weeks
Participant body weights will be measured on a kg scale
次要结局
- Change in T2D diagnosis criteria(Baseline to 52 weeks.)
- Change in % fat free mass (FFM)(Baseline to 16 weeks.)
- Change in % FFM(Baseline to 52 weeks.)
- Change in % body fat(Baseline to 52 weeks.)
研究者
James O. Hill
Primary Investigator
University of Alabama at Birmingham