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临床试验/NCT03969745
NCT03969745已完成不适用

Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men

University of Nottingham2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年6月26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
16
试验地点
2
主要终点
Change in branched chain amino acid uptake

研究概览

简要总结

In the modern era, food access is widely available and it is not uncommon for the time between breakfast and a late night snack to exceed 14 hours. The investigators are interested in studying whether limiting this window to 8 hours will have any beneficial effects of human health as has been demonstrated in animal models. Eight men were asked to restrict their energy intake window to between 8 am and 4 pm for two weeks whilst maintaining their habitual diet (quantity and composition). Improvements in skeletal muscle and whole-body insulin sensitivity were observed but these were potentially confounded by an average weight loss of 1 kg. Therefore an additional control group was recruited to follow a daily caloric deficit of ~400 kilocalories without changing the timing of intake.

详细描述

All participants were monitored for a one week baseline period to establish their habitual physical activity and dietary patterns. This was done using food diaries, interstitial glucose monitors and a combined heart rate + accelerometer device. Participants consumed a standardised evening meal ~12h before visiting the laboratory to assess their metabolic response to a liquid test meal (1g/kg bodyweight dextrose and 0.4g/kg bodyweight protein) using the arterio-venous forearm balance model. Dual-energy X-ray absorptiometry scans, indirect calorimetry measurements and fasted and postprandial vastus lateralis biopsies were also obtained.

From the next day, participants either restricted their daily energy intake window to between 8 am and 4 pm or were prescribed a caloric deficit diet (~400 kilocalories/day) for two weeks. Physical activity, interstitial glucose concentrations and dietary patterns were monitored throughout. After this, participants visited the laboratory again to assess changes in metabolism and body composition.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male between 18 and 35 years old
  • Body mass index between 18 and 27.5 kg.m^-2
  • Regular breakfast consumer, 5 or more days per week
  • Moderate physical activity level (PAL between 1.6 and 2)

排除标准

  • Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (heart or blood) abnormalities including hypertension.
  • Clinically significant abnormalities on screening including ECG abnormalities
  • Routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
  • High alcohol consumption (Routinely >4 units per day)
  • Eating attitudes test (EAT-26) score > 20
  • On an energy-restricted diet
  • Significant body mass fluctuation in previous 3 months (>5%)

研究组 & 干预措施

Time restricted feeding (TRF)

Experimental

Participants restricted their daily energy intake window to between 8 am and 4 pm for two weeks. They were encouraged to not alter the quantity and composition of their diet or alter physical activity patterns.

干预措施: Time restricted feeding (Behavioral)

Caloric deficit

Active Comparator

The investigators observed significant weight loss in the TRF group with participants reporting to consume ~400 kilocalories less per day. Therefore the investigators added a caloric deficit group to control for the effects of weight loss on metabolism. Total energy expenditure was measured for one week and was used to prescribe a 400 kilocalories/day energy deficit diet to follow for two weeks.

干预措施: Caloric restriction (Behavioral)

结局指标

主要结局

Change in branched chain amino acid uptake

时间窗: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink

The arterio-venous forearm balance method was used to assess skeletal muscle branched chain amino acid uptake in micromoles/min.

Change in whole-body insulin sensitivity

时间窗: Pre and post intervention (15 days apart).

The Matsuda Index was used to calculate an index of whole-body insulin sensitivity using values of fasted and postprandial glucose and insulin. Measured in arbitrary units and higher values indicates increased insulin sensitivity. All individual changes will be reported.

Change in glucose uptake

时间窗: Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink

The arterio-venous forearm balance method was used to assess skeletal muscle glucose uptake in micromoles/min.

次要结局

  • Change in substrate metabolism(Pre and post intervention (15 days apart). In each condition there was one measurement in the fasted state and two measurements in the postprandial state.)
  • Change in body composition(Pre and post intervention (15 days apart))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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