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临床试验/NCT01740765
NCT01740765已完成不适用

Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Energy Expenditure

研究概览

简要总结

This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition Research Institute (UNC NRI).

详细描述

Subjects will complete a baseline eucaloric study day. Following this, subjects will be randomized to complete 3 days of overfeeding (150% of baseline eucaloric energy requirements) or 3 days of underfeeding (50% of baseline eucaloric energy requirements). After completing one of these study arms, subjects will cross-over and complete the second arm. All study arms will be separated by two weeks. 24-hour energy expenditure will be measured 3 times during each of 3 day periods. We hypothesize that the impact of over or underfeeding on EE will be evident after 24-hours and will be comparable to 72 hour EE.

研究设计

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

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Postmenopausal
  • •Aged 50-65 years
  • •BMI 25-35kg/m2
  • •Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
  • •Thyroid hormone profile within the normal reference range
  • •No medical condition which may impact the results (e.g. diabetes)
  • •Accustomed to eating regular meals including breakfast

排除标准

  • •Heavy exerciser (defined as >150 minutes/week for more than 3 months)
  • •Abuses alcohol or drugs
  • •Vegetarian

研究组 & 干预措施

Eucaloric Feeding

Experimental

Subjects will complete an initial eucaloric feeding study day. During this study day, subjects will receive 100% of their calorie requirements. 24-hour energy expenditure will be measured.

干预措施: 24-hour energy expenditure (Other)

Underfeeding

Experimental

Following the eucaloric feeding study day, subjects will undergo the underfeeding and overfeeding arms in random order. During the underfeeding study arm, subjects will receive 50% of their calorie requirements (as determined during the initial eucaloric study day) for 3 days. 24-hour energy expenditure will be measured.

干预措施: 24-hour energy expenditure (Other)

Overfeeding

Experimental

Following the eucaloric feeding study day, subjects will undergo the underfeeding and overfeeding arms in random order. During the overfeeding study arm, subjects will receive 150% of their calorie requirements (as determined during the initial eucaloric study day) for 3 days. 24-hour energy expenditure will be measured.

干预措施: 24-hour energy expenditure (Other)

结局指标

主要结局

Energy Expenditure

时间窗: 24-hour energy expenditure will be assessed

24-hour energy expenditure will be assessed using the metabolic chamber at UNC NRI. Energy expenditure will be measured during eucaloric feeding (subjects will receive 100% of calorie requirements), as well as during 24, 48 and 72 hours of under and overfeeding.

次要结局

  • Whole blood transcriptomics(Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch)
  • Plasma metabolomics(Fasting a.m. sample, before lunch, and at 0.5, 2, and 4.5 hours post lunch)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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