Meal Schedule Effects on Circadian Energy Balance in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Oxygen intake
研究概览
简要总结
This study will test will how eating on a particular daily schedule may effect energy, weight gain or loss, and body temperature.
详细描述
Although there have been a large number of studies in humans on the effects of food intake at night, very few studies directly address the hypothesis that inappropriately phased eating or snacking (i.e., at night) in humans disrupts metabolism and respiratory quotient (RQ) patterns and there are no studies that we are aware of that directly measure circadian clock phase relative to timing of food intake while evaluating metabolism. This may be critical, because it is well established that the timing of food intake can also modulate circadian clock phase.
Hypothesis
Food consumption in the subjective night (e.g., 20:00 - 02:00) will result in a different circadian metabolic profile measured by RQ) than food consumed in the subjective day.
Aim 1: To determine if there are daily rhythms of switching between lipid and carbohydrate metabolism in humans that are altered by the timing of food intake. Aim 2: To determine if timing of food intake results in "internal desynchronization" between the metabolic rhythms (RQ) and the rhythm in core body temperature (a marker of central circadian phase).
Aim 3: To determine if body composition has measurable impact on the circadian regulation of metabolism.
In this study we will test human subjects in a specially designed whole-room indirect calorimeter where energy expenditure and RQ will be monitored by indirect calorimetry continuously over 56 hours. Circadian phase and amplitude will be assessed by continuously recording the core body temperature rhythm using the Vital Sense Integrated Physiological Monitoring System in which subjects swallow a telemetry capsule that transmits core body temperature to a data acquisition module. In consultation with a nutritionist at Vanderbilt, we will use a cross-over design in which daily diets have the same caloric and nutritional value but in which the subjects consume the calories that would normally be breakfast as snacks consumed in the late-evening.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to understand the study, provide written informed consent (in English), and be able to fill out the questionnaire
- •Be male or female older than 18 years of age;
- •Have a normal BMI (20-25) or be obese (BMI more than 30);
- •Have a normal basal glucose level (70-100 mg/dL)
- •If female of childbearing potential, have a negative pregnancy test on study day;
排除标准
- •Be pregnant or lactating;
- •Have known sleep, metabolic (e.g., diabetes), or gastro-intestinal disorders except obesity;
- •Had alcohol less than 24 hours before admission;
- •Require assistance with activities of daily living;
- •Have difficulty swallowing
- •Be unable to complete a food and sleep diary
- •Be smokers
研究组 & 干预措施
Normal diet then modified diet
Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM. Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.
干预措施: Normal diet (Behavioral)
Normal diet then modified diet
Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM. Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.
干预措施: Modified diet (Behavioral)
Modified diet then normal diet.
Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM.
干预措施: Normal diet (Behavioral)
Modified diet then normal diet.
Participates in the modified diet skipped breakfast, had lunch at 12:30 PM, dinner at 5:45 PM, and a breakfast equivalent snack at 10:00 PM.Participates in the normal diet will receive 3 meals each day, breakfast at 8:00 AM,lunch at 12:30 PM and dinner at 5:45 PM.
干预措施: Modified diet (Behavioral)
结局指标
主要结局
Oxygen intake
时间窗: 56 hours
Subjects were housed in a whole room calorimeter and oxygen consumption was monitored minute by minute
Carbon dioxide exhaled
时间窗: 56 hours
Subjects were housed in a whole room calorimeter and carbon dioxide was monitored minute by minute
Core body temperature
时间窗: 56 hours
The subjects' circadian phase and amplitude will be assessed by continuously recording the core body temperature rhythm with an ingestible Vital Sense monitor.
Locomotor activity
时间窗: 56 hours
The subject's activity will be assessed throughout the experiment using a Actigraph (GT3X) triaxial monitor attached to the subject's wrist, waist, and ankle.
次要结局
- Determination of Body Mass Index (BMI)(Baseline just prior to entry in the metabolic chamber)
研究者
Terry Page
Professor Emeritus of Biological Sciences
Vanderbilt University