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Glycaemic Response to High REsistant STarch Bread (REST)

2022年2月16日 更新者:Quadram Institute Bioscience
This study evaluates if the consumption of one sbeIIa/b white bread with high resistant starch content will result in a lower blood glucose response and increased satiety compared with reference white bread. All participants will be asked to consume once the sbeIIa/b white bread and the reference white bread during different visits.

研究概览

详细说明

In an attempt to increase dietary fibre intake, research has focused on developing wheat-based food products with novel fibres and starches to complement fibre intake from whole grain foods. Resistant starch is starch that escapes digestion in the small intestine and may be fermented in the large intestine by the microbiota. Resistant starch is a type of dietary fibre and it is normally found in wheat-based foods made from refined flour but only in small amounts. White bread made from sbeIIa/b wheat, which has high levels of resistant starch (a type of fibre), is showing promise in modulating blood glucose response and increasing satiety compared with conventional white bread.

The primary aim of this study is to determine whether consumption of sbeIIa/b white bread at breakfast, gives rise to a lower postprandial blood glucose response compared with consumption of a reference white bread in healthy individuals.

Additional aims of the study include: determining whether consumption of sbeIIa/b white bread by healthy subjects, gives rise to a lower glucose concentration in interstitial fluid, as measured by a Continuous Glucose Monitoring system (CGM), compared with consumption of control white bread; and exploring satiety and energy intake changes in healthy individuals following consumption of sbeIIa/b white bread at breakfast, compared with consumption of control white bread.

研究类型

介入性

注册 (实际的)

21

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Norfolk
      • Norwich、Norfolk、英国、NR4 7UQ
        • Quadram Institute

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Men and women
  • Aged 18 to 65 years
  • BMI between 18-25 kg/m2
  • Non-smokers
  • Those that live within a 40-mile radius of Norwich

Exclusion Criteria:

  • Fasting glucose >6.1 mmol/L and/or HbA1c>42 mmol/mol, as assessed by a fasting blood test
  • Eligibility screening results indicate they are not suitable to take part in this study
  • Smokers (if they have smoked within the 6 weeks prior to the study or during the study)
  • Suffer from allergy, intolerance, or sensitivity to gluten, yeast or any of the food ingredients used in this study
  • Have a known allergy to adhesives that would prevent proper attachment of the Continuous Glucose Monitoring sensors
  • Are pregnant and/or have been pregnant in the last year or are lactating and/or breastfeeding
  • Are currently suffering from, or have ever suffered from eating disorders, any diagnosed gastrointestinal disease, gastrointestinal disorders including regular diarrhoea and constipation (excluding hiatus hernia unless symptomatic) or other inflammatory diseases like rheumatoid arthritis (RA), polymyalgia rheumatica or other connective tissues diseases
  • Have undergone gastrointestinal surgery; this will be assessed on an individual basis
  • Have been diagnosed with diabetes, anaemia as this may affect the study outcome
  • Have been diagnosed with any long-term medical condition that may affect the study outcome (e.g. cardiovascular diseases, cancer)
  • Regularly take over-the-counter medications for digestive/gastrointestinal conditions
  • Use medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including long-term steroids, antibiotics. They may be able to participate if 4 weeks or more have passed from the end of a course such medication
  • Regularly take laxatives (once a month or more) as this may affect blood glucose levels
  • Take certain dietary supplements or herbal remedies and are unwilling to stop taking them (if required) for two weeks prior to and during the study period
  • Are on, or plan to start, a diet programme that may affect the study outcome (e.g. 5:2 fasting diet) unless willing to abstain for 1 month prior to and during the study period
  • Went through a weight change of ≥ 3kg in the preceding 2 months
  • Have a recent history of substance abuse
  • Regularly consume more than 14 units of alcohol a week
  • Are unwilling to suspend smoking and vaping for the duration of the study.
  • Are participating in another research project that involves dietary intervention or blood sampling.
  • Are unwilling to provide GPs contact details
  • Are related to or living with any member of the study team.
  • Are unable to provide written informed consent
  • Have not donated blood or taken part in another dietary intervention in the last 16 weeks and are unwilling to wait until 16 weeks have elapsed
  • Those with abnormal blood pressure measurements

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:sbeIIa/b white bread
sbeIIa/b white bread with high resistant starch content
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
有源比较器:Control white bread
Reference white bread (wild-type)
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast

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
Change in postprandial capillary glucose concentration
大体时间:3.5 hours

Glucose concentration in capillary blood measured by finger prick test after the consumption of sbeIIa/b white bread compared to control white bread.

Measurements will be taken during intervention visit 1 and 2 at -15, -10, -5, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 min.

3.5 hours

次要结果测量

结果测量
措施说明
大体时间
Change in postprandial glucose concentration in interstitial fluid
大体时间:4 hours

Glucose concentration in interstitial fluid measured by continuous glucose monitoring system after the consumption of sbeIIa/b white bread compared to control white bread.

Measurements will be taken during intervention visit 1 and 2 between -30 to 210 min.

4 hours
Ad libitum intake
大体时间:2 hours

Mean energy intake (kcal) at lunch after consumption of sbeIIa/b and control white bread.

Measurements will be taken once during intervention visit 1 and 2.

2 hours
Change in postprandial glucose concentration in interstitial fluid
大体时间:4 hours

Glucose concentration in interstitial fluid measured by continuous glucose monitoring system after the consumption of ad libitum lunch to explore any second meal effects caused by prior intake of either sbeIIa/b white bread and control white bread at breakfast.

Measurements will be taken during intervention visit 1 and 2 between 225 to 465 min.

4 hours
Satiety
大体时间:3 hours

Change of hunger feeling (appetite) will be examined using visual analog scale (0-10), 0 least and 10 greatest.

Measurements will be taken during intervention visit 1 and 2, at 0, 32, 92, 182 min.

3 hours
Sensory questionnaire
大体时间:30 minutes

Sensory perception of sbeIIa/b white bread and control white bread will be evaluated using a nine-point hedonic scale to determine any differences overall acceptability based on specific attributes.

A Just-About-Right (JAR) scale with five anchor points will be used to measure the appropriateness of the level of specific attributes to evaluate aroma, appearance, taste and texture of breads.

Measurements will be taken once during intervention visit 1 and 2.

30 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。

调查人员

  • 首席研究员:Marina Corrado, MSc、PhD student

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)

2020年1月6日

初级完成 (实际的)

2021年4月30日

研究完成 (实际的)

2021年4月30日

研究注册日期

首次提交

2019年12月9日

首先提交符合 QC 标准的

2019年12月12日

首次发布 (实际的)

2019年12月13日

研究记录更新

最后更新发布 (实际的)

2022年2月17日

上次提交的符合 QC 标准的更新

2022年2月16日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • QIB02/2019

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data for primary and secondary outcome measures will be made available

IPD 共享时间框架

Data will be available after publication in scientific journal within 18 months of study completion

IPD 共享访问标准

Data access will be reviewed by the study team

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告(CSR)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

sbeIIa/b white bread的临床试验

3
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