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临床试验/NCT00619008
NCT00619008已完成2 期

Energy and Appetite Regulation by High and Low CHO Diets

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
35
试验地点
2
主要终点
24-hour profiles and AUCs of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1).

研究概览

简要总结

The purpose of this study is to test the hypothesis that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet.

详细描述

The rising epidemic of obesity in the United States is accompanied by widespread public use of low carbohydrate diets for weight loss. The popularity of these diets is due partly to the promise of a "metabolic advantage" that promotes faster weight loss without an overriding sense of hunger. If this claim is true, we hypothesize that a low-carbohydrate diet will impact hormones and other factors that regulate appetite and energy balance, and result in lower energy intake and greater weight loss, than a high complex carbohydrate diet. To test this hypothesis, we will conduct a randomized, controlled feeding trial in which obese adults will be randomly assigned to one of three interventions: a low-carbohydrate-ad libitum diet, a high-carbohydrate-ad libitum diet, or a high-carbohydrate-energy-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. Participants will eat a standardized weight maintenance diet for 3 weeks. Then, for 6-weeks, participants assigned to either ad libitum group will be given their assigned diet at 120% of there estimated energy needs to maintain weight and allowed to eat as much as desired. Participants assigned to the energy-restricted group will be provided a DASH diet at 67% of their estimated energy needs to maintain weight and asked to eat all foods provided. Food intake will be measured daily. Body weight and hunger and satiety scores will be measured three times a week. Body composition and energy expenditure will be measured before and after the intervention. 24-hour profiles of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1) will be measured before, and on first and last days of the intervention, to compare acute and chronic metabolic effects of the diets. The analysis of primary outcomes will be based on repeated measures and longitudinal models methodology. This study offers a unique opportunity to explore how extreme differences in dietary composition, before and after weight loss, affect components of energy balance and markers of central appetite and weight regulation. These results will be used to design hypothesis-driven studies of the identified mediators of appetite and weight regulation in response to dietary manipulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 30-50 kg/m2
  • Age 21-65 years
  • Relative good health

排除标准

  • Major debilitating mental of physical illness that would interfere with participation
  • Renal or hepatic disease, diabetes, gallbladder disease, untreated hyper-or hypothyroidism, poorly controlled hypertension (>3 HT medications)
  • Use of lipid lowering medications
  • Current of recent (within 12 mo) pregnancy or lactation
  • Current excessive use of alcohol
  • Current/recent (within 1 year)use of tobacco products
  • Food allergies, food restrictions, or food preferences that are inconsistent with the research diets

结局指标

主要结局

24-hour profiles and AUCs of hormones and other factors that influence central appetite and weight regulation (insulin, leptin, ghrelin, PYY, GLP-1).

时间窗: Week 2, week 3 and week 9 of intervention

次要结局

  • Energy intake, hunger and satiety ratings(week 2, 3, and 9 of intervention)

研究者

研究点 (2)

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