跳至主要内容
临床试验/NCT03305237
NCT03305237已完成不适用

The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight

University of Aberdeen2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年10月24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
31
试验地点
2
主要终点
Energy balance

研究概览

简要总结

This weight loss study will investigate the impact of calorie distribution across a day (large breakfast meals and smaller evening meals versus small breakfast meals and large evening meals) on body weight, and physiological and behavioral mechanisms regulating energy balance.

Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating will influence energy balance, because morning energy expenditure is amplified in comparison to the evening. This study will allow us to assess whether the increased energy expenditure in the morning is linked to natural biological circadian rhythm or behavioral adaptions.

详细描述

Dietary advice for weight management is broadly based on the assumption that a 'calorie is a calorie' and it does not matter when calories are consumed across the day. Recent evidence has challenged this assumption, suggesting that we may utilize calories more efficiently when consumed in the morning relative to the evening, and this could be used as a beneficial strategy for weight loss - this is a newly developing field of investigation which merges circadian biology with nutrition (chrono-nutrition).

Timing of food consumption is a modifiable factor influencing energy balance and body weight (and thus, disease risk). Previous research has shown that calories ingested at different times of the day have different effects on energy utilization, leading to differential weight loss, even at iso-caloric amounts. This study will aim to increase our understanding of the underlying behavioral and physiological mechanisms associated with differential weight loss and energy balance when calories are consumed predominantly in the morning versus in the evening.

This study will be a cross-over study comparing large breakfast versus large evening meals (percent daily calories split between breakfast, lunch and dinner as 45-35-20 (breakfast-loaded) or 20-35-45 (evening-loaded)) during energy restriction (Fed to measured RMR) on energy balance, through differences in both physiological and behavioural changes in energy expenditure and substrate utilization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ranging from 27-42 kg/m2;
  • Those habitually consuming breakfast (at least 5 times a week).

排除标准

  • women who are pregnant, planning to be pregnant or breastfeeding
  • subjects with food allergies which prevent consumption of the study diet.
  • diagnosis of diabetes, hypertension, renal, hepatic, haematological disease, coronary heart disease, metabolic disease, gastrointestinal disease
  • having given a pint of blood for transfusion purposes within the last month
  • unsuitable veins for blood sampling
  • inability to understand the participant information sheet
  • inability to speak, read and understand the English language
  • those on any prescription medications (other than oral contraceptives) which will adversely affect the study outcomes (i.e. medications affecting, circadian timing, sleep or metabolic function).
  • those on any specific diet regimes
  • those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet).
  • Extremes of chronotypes, sleep patterns and physical activity.

结局指标

主要结局

Energy balance

时间窗: Measured up to day 71 of study

Change in energy balance during each diet protocol (body weight (kg))

次要结局

  • Plasma insulin(Week 1, week 5, week 6, week 10.)
  • Blood lipids(Week 1, week 5, week 6, week 10.)
  • Total Daily Energy Expenditure(4 x 2 weeks. Throughout weeks 2-5 and 7-10.)
  • Resting Metabolic Rate (RMR)(Baseline,week 1, week 5, week 6, week 10.)
  • Gastric emptying(Week 1, week 5, week 6, week 10.)
  • Waist and hip circumference(Week 1, week 5, week 6, week 10.)
  • Gut appetite hormones(Week 1, week 5, week 6, week 10.)
  • Thermic effect of food (TEF)(Week 1, week 5, week 6, week 10.)
  • Body Volume(Week 1, week 5, week 6, week 10.)
  • Bone Mineral Content(Week 1, week 5, week 6, week 10.)
  • Total Body Water(Week 1, week 5, week 6, week 10.)
  • Body Composition(Week 1, week 5, week 6, week 10.)
  • Plasma glucose(Week 1, week 5, week 6, week 10.)
  • Daily Subjective Appetite(Hourly measures for 3 days in week 1,week 5, week 6, week 10.)
  • Postprandial Subjective Appetite(Week 1, week 5, week 6, week 10.)
  • Faecal sample analysis for gut health(Week 1, week 5, week 6, week 10.)
  • Physical activity(Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.)
  • 24 hour blood glucose(Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验