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临床试验/NCT04417205
NCT04417205已完成不适用

Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention

University of Bath2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年2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
34
试验地点
2
主要终点
Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks

研究概览

简要总结

Following the establishment of causal links between breakfast consumption, the individual components of energy balance, and health it is now important to examine and target the underlying biological mechanisms involved to maximise potential health benefits.

To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to take part in phase I (acute design) of a wider project.

详细描述

Causal links between breakfast consumption, the individual components of energy balance, and health have recently been established and it is now important to examine and target the underlying biological mechanisms over a longer period of time to maximise potential health benefits.

Specifically, the substitution of a portion of carbohydrate for protein at breakfast may enhance the potential health benefits of breakfast through targeting distinct mechanistic pathways. Broadly, introducing a greater protein load at breakfast increases insulin secretion and delays gastric emptying, thereby eliciting a potentiated insulin response. In turn this may therefore improve glucose tolerance during a subsequent meal. Additionally, maintenance of euglycaemia following breakfast consumption, coupled with the thermic effect of feeding protein may accentuate the elevated energy expenditure following breakfast observed in previous studies. Finally, both the physical and chemical properties of protein exert a marked satiating effect. Collectively, these mechanisms could interact to maximise the net impact of breakfast on energy balance and associated health outcomes. However, whilst the evidence indicates obvious benefits of feeding a higher protein dose at breakfast, relatively little research has focused on the response to protein over multiple meals/days. Furthermore, and importantly, the mechanisms involved in the second-meal phenomenon and the potential for initial meals of varied composition to target these mechanisms have never been systematically investigated.

To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to undergo a 4 week intervention study in which they will consume one of three breakfasts for 28-days. The breakfast interventions provide will be:

Carbohydrate rich breakfast

Whey protein enriched breakfast

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Where applicable (i.e. the two breakfast feeding interventions) participants will be blinded to the breakfast that they receive for 28-days.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index 18.5-29.9 kg∙m-2
  • Age 18-65 years
  • Able and willing to provide informed consent and safely comply with study procedures
  • Females to maintain record of regular menstrual cycle phase or contraceptive use
  • No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
  • Inclusive to all breakfast habits (e.g. regular skipper / consumer)

排除标准

  • Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
  • Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
  • Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment (e.g. smoking/substance abuse)
  • Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
  • Any reported recent (<6 months) change in body mass (± 3%)

结局指标

主要结局

Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks

时间窗: Baseline and 4-weeks

The postprandial time course response of plasma glucose to the test breakfast and lunch meals

Change in body mass

时间窗: 4 weeks

Participants will be weighed prior to the intervention and again upon completion

Change in expression of circadian clock genes measured in whole blood

时间窗: Baseline and 4-weeks

Pre and post intervention change clock gene expression

Change in physical activity thermogenesis

时间窗: Assessed for 1 week at baseline, 3 days a week during weeks 1-3 of the intervention and again for 1 week in the 4th week of the intervention.

Energy expenditure measured using physical activity monitor

Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks

时间窗: Assessed at baseline and after 4 weeks of the intervention

The postprandial time course response of plasma insulin to the test breakfast and lunch meals

次要结局

  • Change in fuel oxidation during the test breakfast(Baseline and 4 weeks)
  • Change in postprandial incretin hormone response following breakfast and lunch(Baseline and 4 weeks)
  • Change in subjective appetite ratings following breakfast and lunch(Baseline and 4 weeks)

研究者

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

James Betts

Professor James Betts

University of Bath

研究点 (2)

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