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临床试验/NCT00123240
NCT00123240已完成不适用

High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)

Rockefeller University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Visceral adipose tissue

研究概览

简要总结

The purpose of this study is to compare the ability of low calorie high carbohydrate and low calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects. The investigators will also test the effects of these diets on secondary outcomes including body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure, arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.

详细描述

Participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks.

Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. The first 2 weeks consist of a weight stabilization period, during which subjects will be required to consume an average American diet. This is followed by the 6 week weight loss period where subjects will be randomized to either a low calorie high carbohydrate or a low calorie high fat/protein diet. On both diets there will be a 50% calorie deficit compared to the weight stabilization period. This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. Appropriate adjustments will be made to keep the subject's weight stable.

During the entire inpatient study, subjects will consume one multivitamin per day (Centrum, always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited access to zero calorie liquids (water/diet soda) will be available and will be encouraged to maintain one's usual activity level.

Females of reproductive age, need to make sure that they do not become pregnant during the inpatient study. Urine will be tested for pregnancy once during the stabilization and weight maintenance phases of the study.

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
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Man or a woman with a body mass index (BMI) of 30 to 34.9
  • Man with a BMI of 25 to 29.9 with a waist circumference > 102cm (40in)
  • Woman with a BMI of 25 to 29.9 with a waist circumference > 88cm (35in)

排除标准

  • High Blood Pressure
  • High Cholesterol
  • HIV positive
  • Hepatitis B/C positive

结局指标

主要结局

Visceral adipose tissue

时间窗: days 12, 68

次要结局

  • Body composition(days 12, 68)
  • Blood pressure(days 11 and 67)
  • Insulin glucose metabolism(days 13, 15 69, 71)
  • Bone turnover(days 14, 70)
  • Measures of satiety(once a week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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