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临床试验/NCT04293003
NCT04293003已完成不适用

Short-term Metabolic Effects of Morning Energy Restriction Versus Two Different Early-day Nutrition Strategies

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年1月7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
10
试验地点
2
主要终点
Mobilisation of adipose tissue

研究概览

简要总结

A study to address the effects of early-day fasting on fat tissue mobilization in comparison to a typical isocaloric Mediterranean and a low-carbohydrate breakfast.

详细描述

The study design meets a cross-over pattern with 3 different morning visits of 6 hour duration each. After an informed consent is received from the participant, a crude medical history, physical examination and collection of somatometric data through bio-impendance analysis will take place. An intravenous catheter will be placed in the participants forearm.

At zero time point, depending on study visit, participants will either (A) remain fasted (B) start consuming ta pre-prepared zero-carbohydrate 500 kcal test meal (C) start consuming ta pre-prepared 500 kcal test meal with a composition conforming to a standard Mediterannean breakfast. Participants will be given 10 minutes to consume the meal.

Blood samples will be drawn and visual analogue scales (VAS) for hunger and satiety will be filled in at the following time points (min): -15, 0, 15, 30, 60, 90, 120, 180, 240, 300, 360.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • BMI 18-25 kg/m2
  • Willfulness to participate

排除标准

  • Overweight or obesity (BMI>25 kg/m2)
  • Type 1 or 2 diabetes mellitus
  • Uncontrolled thyroid disorders

结局指标

主要结局

Mobilisation of adipose tissue

时间窗: 6 hours

Area Under the Curve (AUC) of free fatty acid (FFA) and beta-Hydroxybutyrate (bOB) concentration

次要结局

  • Degree of satiety induction(6 hours)
  • Mobilisation of gut peptides(6 hours)
  • Degree of appetite suppression(6 hours)

研究者

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

Alexandros Kokkinos

Associate Professor in Internal Medicine

National and Kapodistrian University of Athens

研究点 (2)

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