GIGlycaemic Index Testing of Carbohydrate Containing Foods Using a Standardised Method
food consumption
+ food consumption
Basic Science Study
Summary
Study start date: June 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
NIHR/Wellcome Trust Imperial CRF
London, United KingdomOpen NIHR/Wellcome Trust Imperial CRF in Google Maps