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临床试验/NCT02093572
NCT02093572已完成不适用

Effect of Skipping Breakfast on Metabolic Function

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Determine the effect of skipping breakfast on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity

研究概览

简要总结

The purpose of this study is to test the hypothesis that the disruption of the "normal" (three meals a day) eating pattern and prolonged overnight fasting caused by skipping breakfast: i) alters the expression of specific clock genes and clock gene targets involved in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA) concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying healthy, lean persons either randomized to consume either 3 standard meals per day or omit breakfast and consume 2 meals per day without changing daily calorie intake (skipping breakfast group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males & females
  • 18-55 years old
  • BMI between 18.5 - 29.9 kg/m²
  • Sleeps >7 hours/night
  • Normally consume 3 meals/day, including breakfast

排除标准

  • Pregnancy, lactating or breastfeeding
  • Sleep disorders
  • Significant organ dysfunction
  • Shift or nighttime workers
  • Breakfast skippers
  • People who regularly sleep <7 hours/night
  • Consume excess amounts of alcohol
  • Medications that could alter the results of this study

结局指标

主要结局

Determine the effect of skipping breakfast on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity

时间窗: 3 weeks

Hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labeled trace infusions will be conducted before and after the diet intervention to asses the changes on basal adipose tissue lipolytic activity and skeletal muscle insulin sensitivity.

Determine the effect of skipping breakfast on the diurnal expression of clock genes and downstream metabolic targets involved in regulating adipose tissue lipolytic activity and skeletal muscle insulin action.

时间窗: 3 weeks

Serial biopsy samples (every 6 hours) of adipose tissue and muscle will be obtained during the 24-hour feeding study to evaluate diurnal expression patterns of i) clock genes \[CLOCK, brain and muscle Arnt-like protein-1(BMAL1), period1 (PER1), period2 (PER2), and Dbp D site albumin promoter binding protein (DBP)\] in adipose tissue and muscle and ii) putative downstream clock gene targets associated with lypolysis in adipose tissue \[hormone-sensitive lipase(HSL) and adipocyte triglyceride lipase (ATGL)\], skeletal muscle insulin action \[glucose transporter type 4(GLUT4)\] and skeletal muscle fatty acid metabolism \[cluster of differentiation 36(CD36), uncoupling protein 3 (UCP3) and pyruvate dehydrogenase kinase, isozyme 4(PDK4)\].

Determine the effect of skipping breakfast on 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity.

时间窗: 3 weeks

Multiple blood and skeletal muscle biopsy samples will be obtained during a 24-hour feeding study before and after the diet intervention to assess 24-hour plasma substrate, hormone concentrations and intramyocellular fatty acid mediators of lipotoxicity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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