NCT01530724已完成3 期
Effect of Weight-loss Diet Strategies and Exercise on Dynamics of Body Fat Depots and Metabolic Rate
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- obesity
研究概览
简要总结
The investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Elevated waist circumference:
- •Men: > 40 inches (102 cm)
- •Women> 35 inches (88 cm)
- •Poor dieters with TG>150mg/dL and high-density-lipoprotein cholesterol [HDL-c] <40 mg/dL for men and <50 mg/dL for women
排除标准
- •Pregnant or lactating women
- •Serum creatinine LT 2 mg/dl
- •Disturbed liver function (LT 3 fold level of ALT and AST enzymes)
- •Active cancer
- •Individuals who cannot start physical activity in the gym
- •Individuals that are highly physically active (more than 4 hours/week)
- •Active in other nutritional trial
研究组 & 干预措施
low fat diet
Experimental
Weight-loss diet strategy
干预措施: Weight-loss diet strategy (+) exercise (PA) (Other)
low fat diet
Experimental
Weight-loss diet strategy
干预措施: weight loss (-) exercise (PA) (Other)
low carb diet
Experimental
Weight-loss diet strategy
干预措施: Weight-loss diet strategy (+) exercise (PA) (Other)
low carb diet
Experimental
Weight-loss diet strategy
干预措施: weight loss (-) exercise (PA) (Other)
结局指标
主要结局
obesity
时间窗: 0, 6, 18 months
changes in weight
abdominal obesity
时间窗: 0, 6, 18 months
changes in waist circumference
body fat composition
时间窗: 0, 6,18 months
changes in body fat (MRI)
次要结局
- Epigenetics(0, 6, 18 months)
- Glycemic control(0, 6, 18 months)
- Metabolomic(0, 6, 18 months)
- Lipid profile(0, 6, 18 months)
- Liver function (blood biomarkers)(0, 6, 18 months)
- Inflammatory state(0, 6, 18 months)
- Genetic signature(baseline)
研究者
Iris Shai
Iris Shai, RD PhD
Ben-Gurion University of the Negev
研究点 (1)
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