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临床试验/NCT03866720
NCT03866720已完成不适用

Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute

University of Bath2 个研究点 分布在 1 个国家目标入组 12 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
12
试验地点
2
主要终点
Postprandial glycaemia following breakfast

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 crossover 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 involved to maximised 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 take part a randomised crossover trial that will contrast the acute metabolic responses to a protein-enriched breakfast, with a carbohydrate rich breakfast, and the total omission of breakfast.

研究设计

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

盲法说明

Where applicable (i.e. the two breakfast feeding trials) participants will be blinded to the breakfast that they receive.

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

Postprandial glycaemia following breakfast

时间窗: Plasma glucose time course data over 3 hours following breakfast

The postprandial time course response of plasma glucose to each breakfast meal

Postprandial insulinaemia following ad libitum lunch

时间窗: Plasma insulin time course data over 2 hours following lunch

The postprandial time course response of plasma insulin to the ad libitum lunch following each type of breakfast

Postprandial insulinaemia following breakfast

时间窗: Plasma insulin time course data over 3 hours following breakfast

The postprandial time course response of plasma insulin to each breakfast meal

Postprandial glycaemia following ad libitum lunch

时间窗: Plasma glucose time course data over 2 hours following lunch

The postprandial time course response of Plasma glucose to the ad libitum lunch following each type of breakfast

次要结局

  • Postprandial incretin hormone response following ad libitum lunch(Plasma incretin time course data over 3 hours following breakfast)
  • Fuel oxidation following ad libitum lunch(For 2 hours following the ad libitum lunch)
  • Postprandial incretin hormone response following breakfast(Plasma insulin time course data over 3 hours following breakfast)
  • Subjective appetite ratings following breakfast(For 3 hours following each breakfast)
  • Subjective appetite ratings following ad libitum lunch(For 3 hours following the ad libitum lunch)
  • Fuel oxidation following breakfast(For 3 hours following breakfast)

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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