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临床试验/NCT03839641
NCT03839641已完成不适用

Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Overnight Respiratory Exchange Ratio

研究概览

简要总结

The overarching aim of this study: To determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to nadir, slope).

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
Double (Investigator, Outcomes Assessor)

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

  • Eligibility criteria include:
  • Healthy male or female
  • Ages 18-40 y
  • BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
  • Are willing to consume pre-prepared meals
  • Are willing to maintain current physical activity, sleep schedule, and dietary habits during the study.
  • Medically cleared for participation in the study by Medical Investigator

排除标准

  • Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:
  • Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
  • Currently working shift work
  • Smoking or use of tobacco products within the last 3 months
  • Amenorrhea (or absence of regular monthly cycles)
  • History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
  • Average screening blood pressure >140/90 mmHg
  • Previous bariatric surgery (or other surgeries) for obesity or weight loss
  • Use of medications affecting metabolism or sleep
  • History of neurological disease
  • History of cardiovascular disease (or other chronic diseases)
  • Pregnant, planning to become pregnant, or breastfeeding
  • Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over the last 3 months.

结局指标

主要结局

Overnight Respiratory Exchange Ratio

时间窗: 12 hours

12-h mean of respiratory exchange ratio following each meal type. measurement interval = 12h following start of meal (7pm) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

次要结局

  • Peak Increase in Respiratory Exchange Ratio(4 h)
  • Peak Decrease in Respiratory Exchange Ratio(12 h)
  • Sleep Respiratory Exchange Ratio(3 h)
  • Slope of Respiratory Exchange Ratio(12 h)
  • Time to Peak Respiratory Exchange Ratio(12 h)
  • Time to Nadir Respiratory Exchange Ratio(12 h)

研究者

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

David McDougal

Assistant Professor-Research

Pennington Biomedical Research Center

研究点 (2)

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