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The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses

2021年3月8日 更新者:Imperial College London
Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.

研究概览

地位

完全的

条件

详细说明

Rationale:

There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.

To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:

Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.

All of which will contain the same macro and micro nutrients from the same food sources

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Gender: male and female
  • Age ≥ 18 years ≤ 65 years
  • Normal weight as classified by BMI 20-29.9 kg/m2
  • Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
  • Willingness and ability to understand, participate and to comply with the study requirements
  • Willingness and ability to give written informed consent

Exclusion Criteria:

  • Has thyroid defects
  • Under hormone or steroids therapy
  • Is pregnant or lactating (female)
  • Had given birth within the past year (female)
  • Is taking drugs that could affect appetite or plasma glucose levels.
  • Is taking natural remedies that modulate appetite or plasma glucose levels.
  • Has excessive alcohol intake
  • Had blood donation within 12wks prior to start date
  • Psychiatric illness
  • Smokers
  • History of any disease with unknown outcome
  • Has diabetes
  • Has nut allergy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:whole chickpea
a test meal containing 26g available carbohydrates from chickpea (full structure)

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

实验性的:flour chickpea
a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

实验性的:intact cell chickpea
a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)

all three meals are isocaloric but different in the chickpea structure( physical form):

• Whole chickpea, flour chickpea, intact cell flour chickpea

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Post-prandial Glucose Concentrations
大体时间:before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.

Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.

Data were not collected for intact cell chickpea hummus

before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.
Post-prandial Blood Insulin Concentrations
大体时间:before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.
Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.

次要结果测量

结果测量
措施说明
大体时间
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)
大体时间:before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.

Blood GIP concentrations were assessed for each participant after each test meal: whole chickpea hummus, and Flour chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.

Data were not collected for intact cell chickpea hummus

before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.
Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)
大体时间:baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
Blood GLP-1 concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.
baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.
Energy Intake at a Meal Given in Excess
大体时间:post consumption of the test meal at 120 minutes
The difference in ad libitum food intake after 210 minutes post test meal to test the difference of energy intake following whole chickpea hummus, flour chickpea hummus, and intact cell chickpea hummus.
post consumption of the test meal at 120 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年7月1日

初级完成 (实际的)

2017年5月1日

研究完成 (实际的)

2018年7月1日

研究注册日期

首次提交

2017年9月1日

首先提交符合 QC 标准的

2018年1月31日

首次发布 (实际的)

2018年2月6日

研究记录更新

最后更新发布 (实际的)

2021年4月2日

上次提交的符合 QC 标准的更新

2021年3月8日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 15HH3069

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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