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临床试验/NCT04924517
NCT04924517Unknown不适用

The Effect of 4 Days of Extended Evening Fasting on Metabolic Health, Energy Balance and Appetite

Nottingham Trent University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年9月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Glycaemic control (Post intervention)

研究概览

简要总结

This study will compare metabolic and feeding behaviour responses to 4 days of extended evening fasting vs. a control trial

详细描述

Humans have evolved as a diurnal species, internally governed by the circadian system, which dictates our hormone regulation. 'Chrononutrition' is a sub-discipline which combines food timing with circadian physiology. The most popular method of time-restricted feeding in the UK is to skip breakfast. However, data from several meta-analysis have shown that skipping breakfast is associated with weight gain and insulin resistance, likely due to eating later into the evening/night and therefore, out of sync with our circadian rhythm. Recent research has shown that skipping dinner (evening fasting) has improved markers of cardio-metabolic health in clinical populations, although these are typically from longer-term studies. Despite these promising findings, it is not yet known whether these findings are population specific.

Therefore, the investigators are interested in examining the metabolic response pre and post intervention to see whether these promising findings can translate into a healthy population. Furthermore, the investigators will be monitoring subjective appetite, energy intake and expenditure to assess whether there is any short-term adaptation to a specific feeding window.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smokers.
  • Have maintained a stable weight for 6 months (self-reported).
  • No history of gastric, digestive, cardiovascular or renal disease (self reported).
  • Female specific: must be using a monophasic, low dose combined OCP (containing less than 50μg oestradiol and a synthetic progestin) OR females with regular menstrual cycles (self-reported).

排除标准

  • Severe food allergies, dislike or intolerance of study foods or drinks.
  • Currently undergoing a lifestyle intervention (structured diet or exercise)
  • Diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise.
  • Use of medication or supplements that may affect hormone concentrations.
  • Excessive alcohol consumption (>14 units/week).
  • Intensive training schedule (>10 hours/week).
  • Female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (<24 d), long (>35 d), or irregular menstrual cycles.

结局指标

主要结局

Glycaemic control (Post intervention)

时间窗: 3.5 hours following the standardised breakfast meal on day 4.

A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.

Glycaemic control (Baseline)

时间窗: 3.5 hours following the standardised breakfast meal on day 1.

A metabolic assessment lasting 3.5 hours will take place following a standardised, laboratory-based meal. The investigators will be taking periodic capillary and venous blood samples to measure post-prandial glucose and insulin, which together comprise 'glycaemic control'.

Energy Intake (Kilocalories)

时间窗: Day 1 to day 4.

Energy intake will be measured both during lab and outside of the laboratory when the participants are free-living. During lab, energy intake will be measured through ad-libitum feeding buffet where 20 minutes will be permitted to eat as much or as little as they desire, until 'comfortably full and satisfied', followed by post-feeding measurement of the remaining food. Outside of laboratory feeding will also be monitored through food diary's and weighing any investigator issued meals.

Energy expenditure

时间窗: Day 1 to day 4.

Energy expenditure will be measured via a chest-worn device (Actiheart) which combines heart rate and accelerometry to gauge calories expended.

次要结局

  • Cortisol awakening response(Five samples will be collected by the participant within the first hour of waking on day 5.)
  • Visual Analogue Scale for Subjective Ratings of Appetite(Every 2 hours between 8am-10pm from day 1 to day 4.)
  • PYY (appetite hormone)(3.5 hours following the standardised breakfast meal on day 1 and day 4.)
  • Carbohydrate oxidation(During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min])
  • Fat oxidation(During laboratory visits on day 1 and day 4 [baseline, 60min, 120min, 180min])
  • Acylated Ghrelin (appetite hormone)(3.5 hours following the standardised breakfast meal on day 1 and day 4.)

研究者

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

William Mode

Principle Investigator

Nottingham Trent University

研究点 (2)

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