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临床试验/NCT06821620
NCT06821620已完成不适用

Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.

St. Mary's University, Twickenham1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月9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
60
试验地点
1
主要终点
Glucose response

研究概览

简要总结

The risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. Previous research suggests eating a protein enriched breakfast can improve glucose response. Therefore, the present study will investigate if the version of the MTNR1B gene that people have is associated with their glucose response after breakfast. Also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. Measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. These findings can be used to provide personalised nutrition advice which may reduce the risk of T2D.

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

Breakfast condition - high carbohydrate or protein enriched

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •aged 18-48 years*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers.

排除标准

  • •aged < 18 or > 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.

研究组 & 干预措施

High carbohydrate breakfast

Active Comparator

干预措施: Breakfast (Dietary Supplement)

Protein enriched breakfast

Experimental

干预措施: Breakfast (Dietary Supplement)

结局指标

主要结局

Glucose response

时间窗: 120 minutes

Area under the curve

次要结局

  • CGM metrics - mean glucose(14 days)
  • CGM metrics - Time in range(14 days)
  • CGM metrics - glycaemic variability(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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