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临床试验/NCT04151927
NCT04151927已完成不适用

Effects of an Overnight, 8-hour Low Oxygen Exposure on Resting Energy Expenditure and Appetite: a Pilot Study

Florida State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年12月11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
20
试验地点
2
主要终点
Resting metabolic rate (kcal/d) following exposure to NH or NN conditions

研究概览

简要总结

This research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) and another night in NN (control) conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to ~1000 feet elevation).

详细描述

Weight loss is a common factor reported in lowlanders traveling to high altitudes. Although the exact cause is unknown, studies have shown that weight loss at high altitude is associated with the amount of time and severity of the altitude exposure. Upon arrival to high altitude (≥ 5000 feet), numerous physiological adaptations occur that may promote weight loss, such as increased energy expenditure and reduced appetite. The breadth of current altitude research is limited by the logistical and monetary constraints of traveling to remote locations or access to an altitude chamber. A more logistically feasible alternative is the simulation of low oxygen conditions at sea level, using a commercially available tent and generator system to reduce ambient oxygen concentrations. The current research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) and another night in NN (control) conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to ~1000 feet elevation). In the morning, following NH or NN exposure, resting metabolic rate will be measured using indirect calorimetry, appetite using an ad libitum buffet meal protocol, and heart rate variability by electrocardiogram. It is hypothesized that exposure to overnight NH will result in increased resting metabolic rate, decreased appetite, and decreased heart rate variability.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 20 - 45 years
  • Body mass index between 18.5 - 24.5 kg/m2
  • Born at altitudes less than 2,100 meters (~7,000 feet)
  • Currently residing in Tallahassee, Florida or the surrounding area
  • Not taking any medication(s) that interfere with metabolism or oxygen delivery/transport for four weeks before and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers, and/or any medication that depresses ventilation, diuretics, alpha, and beta-blockers).
  • Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study
  • Willing to spend two overnight visits on the Florida State University campus.

排除标准

  • Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last two months
  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • Prior diagnosis of apnea or other sleeping disorders
  • Prior diagnosis of high-altitude pulmonary edema or high-altitude cerebral edema
  • Prior diagnosis of anemia or sickle cell anemia/trait
  • Present condition of alcoholism, anabolic steroid, or other substance abuse issues
  • Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past six months.
  • Allergies or intolerance to foods included in the standardized or ad libitum meal (e.g., lactose intolerance/milk allergy)

结局指标

主要结局

Resting metabolic rate (kcal/d) following exposure to NH or NN conditions

时间窗: 8 hours

Resting metabolic rate will be accessed using indirect calorimetry (TrueOne 2400, Parvo Medics, Salt Lake City, UT) following 8 hours of overnight exposure to NH or NN.

次要结局

  • Objective appetite following exposure to NH or NN conditions(8 hours)
  • Food preferences following exposure to NH or NN conditions(8 hours)
  • Fasting and postprandial subjective appetite following exposure to NH or NN conditions(Subjective appetite will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure)
  • Energy intake following exposure to NH or NN conditions(8 hours)
  • Fasting and postprandial hunger following exposure to NH or NN conditions(Hunger will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure)
  • Fasting and postprandial satiety following exposure to NH or NN conditions(Satiety will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure)
  • Fasting and postprandial prospective food consumption following exposure to NH or NN conditions(Prospective food consumption will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure)
  • Macronutrient intake following exposure to NH or NN conditions(8 hours)
  • Prevalence of acute mountain sickness following exposure to NH or NN conditions(8 hours)
  • Continuous oxygen saturation during exposure to NH or NN(8 hours)
  • Sleep quality following exposure to NH or NN conditions(8 hours)
  • Heart rate variability following exposure to NH or NN conditions(8 hours)
  • Severity of acute mountain sickness following exposure to NH or NN conditions(8 hours)

研究者

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

Claire E. Berryman

Assistant Professor

Florida State University

研究点 (2)

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