跳至主要内容
临床试验/NCT02809482
NCT02809482已完成不适用

Pilot Study to Examine the Impact of Overfeeding on Peripheral Clock Gene Expression in Humans

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年7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
10
试验地点
1
主要终点
Expression of clock genes in adipose tissue.

研究概览

简要总结

Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene expression in peripheral tissues resulting in a deleterious re-programming of the circadian metabolome. Studies in humans have only superficially investigated how the circadian clock machinery is impacted by nutritional signals. The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo cell culture approach the investigators will examine the impact of 3-days of HF-OF compared to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This pilot project will serve as a launch point for designing future studies into the effects of diet and exercise on the circadian control of metabolism in adipose tissue depots as well as other tissues (e.g. muscle).

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
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •males and females aged 20-35 yr;
  • •BMI 25-35 kg/m2 and weight stable (±2kg in past 2mo);
  • •non-smoker;
  • •sedentary to moderately active (≤3 days of exercise per week ≤30 min of exercise per session);
  • •sleeping pattern of >7 hours to 9.25 hrs of sleep/night.
  • •subjects will be asked to identify themselves as regular consumers of 3 balanced meals per day by answering the question: "Do you eat breakfast, lunch, and dinner on ≥ 5 days per week?"

排除标准

  • •Smoker (current or within the previous 3 months);
  • •Use any medication that could affect lipid metabolism, insulin signaling, or sleep;
  • •Pregnant women will not be enrolled in the study;
  • •Have a job that involves shift work;
  • •Dwelling below Denver altitude (1,600 m) a year prior to testing;
  • •Travel across more than one time zone 3 wk before a study;
  • •chronic health conditions such as diabetes, hyper or hypothyroidism, renal or liver disease, anemia, or cancer;
  • •Regularly go to sleep after midnight;
  • •o Subjects will be excluded if they are identified as having night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
  • •Allergy to lidocaine or similar compound;
  • •Have one or more of the following out-of-range values measured on a fasting blood sample:
  • •glucose > 110 mg/dl,
  • •thyroid stimulating hormone <0.5 or >5.0 µU/ml.
  • •Subjects who may be:
  • •anemic (hemoglobin < 14.5 g/dl men, <12.3 g/dl women ),
  • •have abnormal liver function tests (alanine amino transferase > 47 U/l, aspartate aminotransferase, > 47 U/l, alkaline phosphatase <39 or >117 U/l) or creatinine (>1.1 mg/dl).

研究组 & 干预措施

Eucaloric Feeding

Other

干预措施: Eucaloric feeding (Other)

Overfeeding

Other

干预措施: Overfeeding (Other)

结局指标

主要结局

Expression of clock genes in adipose tissue.

时间窗: Measured through study completion, an average of 4 weeks.

Gene expression measured at two time points from abdominal fat.

次要结局

  • Gene expression of key cellular fuel sensors thought to be controlled. and/or influenced by peripheral clocks(Measured through study completion, an average of 4 weeks.)
  • Expression of clock genes in blood monocytes.(Measured through study completion, an average of 4 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验