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临床试验/NCT05806489
NCT05806489已完成不适用

Effect of Intermittent Fasting on Glycaemic Variability in Healthy Subjects

Josip Juraj Strossmayer University of Osijek2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年1月26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
Blood glucose

研究概览

简要总结

The aim was to test the difference in glycemic variability after meal consumption during intermittent fasting and the usual diet.

详细描述

Healthy participants were recruited for this crossover study aiming to determine the difference in glycemic variability after meal consumption while practicing intermittent fasting and the usual diet. Prior to the protocol assignment, participants were followed for 3 days - they were instructed to maintain their usual sleep pattern, level of physical activity and diet. Control of dietary pattern was conducted by using the 3-day food diary. Day zero was preparation day for the protocol (Intermittent fasting or Control diet) when all participants received individualized 3-day diet plan. Each protocol lasted 3 days with a 7-day washout period. Each protocol consisted of 3 meals per day, each providing a third of the total energy requirement. Control diet protocol was set at 12 hours eating/12 hours fasting, and Intermittent fasting protocol 6 hours eating/18 hours fasting. Blood glucose was measured at zero, 15, 30, 45 and 90 minutes after meal consumption. Before breakfast, blood glucose was measured also at minus 5 minutes prior meal consumption.

研究设计

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

入排标准

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

入选标准

  • Body Mass Index in the range between 18.5 and 29.9 kg/m^2
  • stable sleep pattern (going to bed between 21:30h and midnight)
  • for women: regular menstrual cycle lasting between 21 and 35 days, with average bleeding time 2 to 6 days

排除标准

  • Body Mass Index below 18.5 or above 29.9 kg/m^2
  • irregular sleeping pattern
  • work in nightshift
  • high intensity workout routine
  • irregular dietary patterns (e.g. skipping meals)
  • regularly fasting for more than 15 hours per day
  • diagnosis of diabetes (or other conditions related to glycemic disorders)
  • hypertension or other cardiovascular disease
  • neurologic conditions
  • disease affecting metabolism (like liver, kidney, thyroid or lung)
  • use of medications for glycemia, hypertension, steroids, adrenergic stimulators, laxatives or supplements affecting glycemia, circadian rhythm, sleep or metabolism in general

结局指标

主要结局

Blood glucose

时间窗: 3 days per protocol

Change in blood glucose

Glycemic variability

时间窗: 3 days per protocol

Coefficient of Variation expressed as the ratio between standard deviation and mean blood glucose

次要结局

未报告次要终点

研究者

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

Ines Banjari

Associate Professor, Clinical Nutrition Specialist

Josip Juraj Strossmayer University of Osijek

研究点 (2)

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