NCT01051674已完成4 期
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.
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
- 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
- •BMI 30.0-42.0 kg/m2
- •English-speaking
排除标准
- •Pregnancy
- •Lactation
- •Acute or chronic infection
- •Type 1 diabetes
- •Participation in another trial
- •Active cancers
- •Currently using Byetta
- •Currently on weight loss medication
- •Weight loss of more than 4 lbs. within the last 3 months
- •Active eating disorder
- •Gastrointestinal problems that may be worsened by a high fiber intake
结局指标
主要结局
Weight
时间窗: 1 year
次要结局
- Lipid profiles(1 year)
- Gastrointestinal hormones(1 year)
- Waist circumference(1 year)
- C-reactive protein(1 year)
- Blood glucose(1 year)
- Serum insulin(1 year)
- Hemoglobin A1c(1 year)
研究者
研究点 (2)
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