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临床试验/NCT00315354
NCT00315354已完成不适用

Popular Diets, Metabolism, and CVD Risk

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年4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
24
试验地点
2
主要终点
resting energy expenditure using indirect calorimetry in the fasting state

研究概览

简要总结

The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease risk factors following weight loss in obese young adults in a feeding study

详细描述

For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD). Over the last few years, very low carbohydrate (Atkins-type) diets have achieved great popularity, with publication of several studies suggesting greater weight loss and improvements in CVD risk factors over 3 to 6 months. Recently, a third dietary approach focused on glycemic index (GI) has generated interest. However, few studies have compared the effects of these diets on body weight regulation and risk for CVD. The primary hypotheses of this study are that any diet that lowers the postprandial rise in blood glucose (very-low-carbohydrate or low-GI) will have beneficial effects on the physiological adaptations to weight loss and on some CVD risk factors. However, other CVD risk factors will be adversely affected by a very-low-carbohydrate vs. a low-GI diet. Preliminary data provide strong support for these hypotheses, by showing that resting energy expenditure declines less and CVD risk factors improve more with weight loss on a low-glycemic load diet compared to a conventional low-fat diet. This application proposes a cross-over feeding design to study the effects of three diets following 12.5% weight loss in obese young adult subjects (n = 24, age 18 to 40 years). The diets are: 1) conventional low-fat, with 60% carb, 20% fat, 20% protein; 2) low-GI with 40% carb, 40% fat, 20% protein; and 3) very-low-carbohydrate with 10% carb, 60% fat, 30% protein. The primary outcome is resting energy expenditure (indirect calorimetry). Secondary outcomes include total energy expenditure (doubly labeled water), thermic effect of food (indirect calorimetry), physical activity (accelerometry), insulin resistance and B-cell function (frequently-sampled OGTT), blood lipids, blood pressure and measures of systemic inflammation and coagulopathy. This study should have major public health implications to the millions of Americans currently following diets to decrease body weight and risk for heart disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥ 27 kg/m2
  • Willing and able to come to the GCRC 5 days per week to consume a supervised meal and pick-up food for all other meals
  • Available for scheduled hospital admissions
  • Willing to abstain from alcohol consumption for the duration of the study
  • If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)

排除标准

  • Weight > 350 lbs
  • Change in body weight (± 10%) over preceding year
  • Taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
  • Smoking (1 cigarette in the last week)
  • High levels of physical activity
  • Currently following a special diet
  • Abnormal laboratory screening tests
  • Type 2 diabetes mellitus
  • Allergies or aversions to foods on the study menu
  • Previous diagnosis of an eating disorder or any other mental health disorder
  • If female, pregnant in the past 12 months or planning to become pregnant during the study period
  • If female, lactating in the preceding 12 months
  • If taking birth control medication, change in medication in previous 3 months or plans to change medication during the study period

结局指标

主要结局

resting energy expenditure using indirect calorimetry in the fasting state

时间窗: end of each dietary period

thyroid function tests

时间窗: end of each dietary period

insulin resistance assessed by frequently-sampled oral glucose tolerance test

时间窗: end of each dietary period

次要结局

  • blood pressure(end of each dietary period)
  • total energy expenditure using doubly labeled water methodology(end of each dietary period)
  • thermic effect of food using indirect calorimetry(end of each dietary period)
  • plasminogen activator inhibitor-1(end of each dietary period)
  • Metabolomic analysis(end of each dietary period)
  • serum lipids(end of each dietary period)
  • Core temperature(End of each dietary period)
  • fibroblast growth factor-21(end of each dietary period)
  • trimethylamine N-oxide(fasting and postprandial, end of each dietary period)
  • Uric acid(end of each dietary period)
  • physical activity using accelerometry(end of each dietary period)
  • insulin 30 minutes after oral glucose (as an effect modifier)(baseline)
  • heme-oxygenase(end of each dietary period)
  • C-reactive protein(end of each dietary period)
  • hunger/appetite(end of each dietary period)
  • Irisin(end of each dietary period)
  • alanine aminotransferase(end of each dietary period)
  • ghrelin(fasting and postprandial, end of each dietary period)
  • gastric inhibitory peptide(fasting and postprandial, end of each dietary period)
  • GLP1(fasting and postprandial, end of each dietary period)
  • Amylin(fasting and postprandial, end of each dietary period)
  • chemerin(end of each dietary period)
  • secreted frizzle-related protein-4(end of each dietary period)
  • Leptin(end of each dietary period)
  • insulin(fasting and postprandial, end of each dietary period)
  • PYY(fasting and postprandial, end of each dietary period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David S. Ludwig, MD, PhD

Professor

Boston Children's Hospital

研究点 (2)

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