跳至主要内容
临床试验/NCT01833689
NCT01833689招募中不适用

Glycaemic Index Testing of Carbohydrate Containing Foods Using a Standardised Method

Imperial College London1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
glycaemic index

研究概览

简要总结

The objective of this study is to assess the effect that dietary carbohydrates have on blood sugar by measuring the glycaemic index. The glycaemic index is a comparison between the effect of equal amounts of carbohydrate from a test food compared to a standard (in this case glucose) on blood sugar.

Different foods that contain different carbohydrates have different effects on blood sugars. This is of interest as a number of studies have shown that the level of sugar in the blood after a meal relates directly to the risk of developing heart disease and diabetes. The aim of collecting this data is to be able to give advice to people about the carbohydrates they eat to reduce the risk of diabetes and heart disease.

详细描述

The study is a randomized cross-over controlled trial: the order of the test foods will be randomized by an independent internet-based program; each participant will be asked to consume all the products; the test food will be compared with a control (in this case 50g glucose).

Suitable subjects will be invited for a screening visit to check for eligibility criteria. Body weight and height measurements will be taken as well as a standard biochemical and haematological screen. If they are eligible and willing to take part, volunteers will be entered into a database and contacted when a GI test becomes available. Volunteers may take part in more than one GI testing up to a maximum of 40 visits per year. Volunteers may withdraw from the database or the study at any time without giving any reason.

Subjects will be asked to come for a set amount of visits for each GI test depending on the number of product that need to be tested (minimum 3 maximum 12 visits for each testing). The volunteers will be informed of the number of visits before they enter the GI testing. For each visit, subjects are tested in the morning after a 10-12h overnight fast.

Three fasting blood samples are taken (-5, -3, -1) 2 minutes apart after which subjects consume the test meal or reference food at an even rate over 15 min. All subjects are asked to record the time it takes in minutes to consume the test food/reference. Further blood samples are taken at 15, 30, 31, 32, 45, 60, 90 and 120 min after the beginning of the meal. The test meal and reference food should be consumed with a 250ml drink of water. This remains constant for each of the tests in the series.

Blood is obtained by finger-pricking using disposable Unistix needles. In previous studies, capillary blood has yielded less between-subject variation in GI. Instant glucose analysers will be used.

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
None

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

  • BMI 18.5-27 kg/m2
  • age 18-65 years

排除标准

  • chronic disease
  • glucose impairment
  • pregnancy

研究组 & 干预措施

food consumption: control

Placebo Comparator

The control product will be 50g glucose powder dissolved in 250ml of water

干预措施: food consumption (Dietary Supplement)

food consumption: product

Active Comparator

The test food will provide 50g of available carbohydrate

干预措施: food consumption (Dietary Supplement)

结局指标

主要结局

glycaemic index

时间窗: 1-2 months depending on product

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验