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临床试验/NCT03276442
NCT03276442Unknown不适用

Biological Rhythms in Metabolic Tissues: Impact of Diet

Uppsala University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
2
主要终点
Changes in clock gene & associated omic circadian rhythms

研究概览

简要总结

Metabolism is increasingly recognized as being highly regulated by anticipatory biological rhythms (circadian rhythms or "biorhythms"), which are driven by molecular feedback loops, and which are approximately 24 hours long ("circa diem"). These circadian rhythms exist both centrally, in the brain, but also in the periphery, and are specific to many tissues depending on their main biological function or functions. Whereas these circadian rhythms have been thoroughly characterized in other organisms, their role in humans remain poorly understood, partly because of the difficulty in studying these rhythms in peripheral tissues. The investigators therefore aim to characterize these rhythms in primarily skeletal muscle and adipose tissue in healthy young volunteers (using the so-called constant routine paradigm), and how these rhythms interact with one another at various genetic and molecular levels. At the same time, the investigators aim to study how an unhealthy vs. healthy diet can alter these circadian rhythms, and how they interact with circadian rhythms in other tissue compartments such as those expressed by blood cells.

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

盲法说明

In the crossover subgroup condition, participants will not be briefed about what diet they will receive before the actual onset of the dietary intervention

入排标准

年龄范围
18 Years 至 32 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-33 yr
  • Healthy (self-reported) and not on medication
  • BMI 18-28 kg/m2 (and waist circumference <102 cm), and weight stable (±5% body weight in past 6 months)
  • Non-smoker and non-nicotine user
  • Regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night
  • Sedentary to moderately active with regular exercise habits the last 2 months
  • Regular daily meal pattern with 3 main meals

排除标准

  • Major or chronic illness, e.g. diabetes, renal disease or inflammatory bowel disease
  • Current or history of endocrine or metabolic disorders
  • Psychiatric or neurological disorders (e.g. bipolar disorder, epilepsy)
  • Frequent gastrointestinal symptoms
  • Chronic medication
  • Any sleep disorder (e.g. irregular bedtimes, symptoms of insomnia)
  • Any issues with or allergies against the provided food items or utilized anesthesia
  • Shift work in the preceding three months or for a long duration
  • Time travel over two time zones in the preceding month
  • Too much weight gain or weight loss in the preceding 6 months
  • Pregnancy

研究组 & 干预措施

Healthy diet

Experimental

'Low-fat dietary intervention' to be administered to participants

干预措施: Low-fat dietary intervention (Other)

Unhealthy diet

Experimental

'High-fat dietary intervention' to be administered to participants

干预措施: High-fat dietary intervention (Other)

结局指标

主要结局

Changes in clock gene & associated omic circadian rhythms

时间窗: Measured repeatedly (every 6 hours for 24 hours) during a period of extended wakefulness, following each dietary intervention (i.e. over a total period of 6-7 weeks)

Changes in clock gene \& associated clock-regulated \& clock-independent metabolic and omic circadian rhythms (e.g. in epigenome, transcriptome, metabolites) in peripheral tissues (primarily skeletal muscle and adipose tissue), and interplay between these rhythms across the 24-h period and under the different dietary conditions

次要结局

  • Wakefulness-induced changes and subsequent recovery at omic levels(Following each dietary intervention (i.e. over a total period of 6-7 weeks), measured repeatedly (every 2-6 hours for 24 hours) during a period of extended wakefulness, and after recovery sleep)
  • 24-h rhythms in blood(Measured repeatedly (every 2-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks))
  • Diet-induced changes in gut microbiota and relation to circadian rhythms(Measured throughout study participation, i.e. on average over 6-7 weeks)
  • Energy expenditure rhythms(Measured repeatedly (every 2 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks))
  • Urine metabolite rhythms(Measured throughout study participation, i.e. on average over 6-7 weeks)
  • Rhythms of blood markers of damage to the central nervous system(Measured repeatedly (every 1-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks))
  • 24-h rhythms in saliva(Measured repeatedly (every 2-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks))
  • Central circadian rhythms(Measured repeatedly (every 1-3 hours over 24 hours) during a period of extended wakefulness and after subsequent recovery, following each dietary intervention (i.e. over a total period of 6-7 weeks))

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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