NCT01034046Unknown不适用
Weight Loss and Visceral Fat Responses to Different Diet Compositions
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in weight in kg
研究概览
简要总结
The purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. The hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females between 18 and 65 years of age.
- •BMI 30-40 kg/m2
- •Stable weight within 10 lb (+/-) for last 2 months
排除标准
- •Pregnant or lactating.
- •Must not currently be part of a structured weight loss program
- •Taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, Byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin.
- •Beck Depression Inventory (BDI Score >19 and/or positively endorses the suicide question on the BDI-II)
- •Taking any chronic medication that has not had a stable dose for 1 month or longer.
- •Diabetes mellitus defined as a fasting glucose ≥ 126 mg/dL on screening.
- •Taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (Seroquel, Zyprexa, and Risperdal) and/or anorectics).
- •Clinically significant laboratory abnormalities at the opinion of the investigators.
- •History of Bariatric Surgery
- •A history of:
- •Type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
- •Liver disease, such as cirrhosis, or chronic active hepatitis B or C.
- •Use of investigational drugs within 30 days of visit 1
- •A pacemaker.
- •Hospitalization for depression in the past 6 months, history of moderate to severe major depression.
- •Any other condition that in the investigators' or sponsor's opinion could interfere with the results of the trial.
结局指标
主要结局
Change in weight in kg
时间窗: 24 weeks
次要结局
- Change in visceral fat via bioimpedance(24 weeks)
研究者
研究点 (2)
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