Glycaemic Index of Foods in Healthy Volunteers (GI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01833689
First received: April 12, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: food consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Glycaemic Index Testing of Carbohydrate Containing Foods Using a Standardised Method

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • glycaemic index [ Time Frame: 1-2 months depending on product ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: food consumption: control
The control product will be 50g glucose powder dissolved in 250ml of water
Dietary Supplement: food consumption

Reference food The reference food is 50 g glucose powder dissolved in 250ml water

Test foods The test foods are prepared according to manufacturer's instructions, representing the food as normally consumed. The test foods are consumed once only on separate occasions as a portion providing 50g of available carbohydrate.

Breakfast cereals should be consumed with 150 ml milk which is additional to the 50 g available carbohydrate in the cereal. In testing breakfast cereals, the reference food must also be consumed with an additional 150 ml milk.

Active Comparator: food consumption: product
The test food will provide 50g of available carbohydrate
Dietary Supplement: food consumption

Reference food The reference food is 50 g glucose powder dissolved in 250ml water

Test foods The test foods are prepared according to manufacturer's instructions, representing the food as normally consumed. The test foods are consumed once only on separate occasions as a portion providing 50g of available carbohydrate.

Breakfast cereals should be consumed with 150 ml milk which is additional to the 50 g available carbohydrate in the cereal. In testing breakfast cereals, the reference food must also be consumed with an additional 150 ml milk.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
  • chronic disease
  • glucose impairment
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833689

Contacts
Contact: Gary Frost, BSc SRD PhD 020 8383 8037 g.frost@imperial.ac.uk

Locations
United Kingdom
NIHR/Wellcome Trust Imperial CRF Recruiting
London, United Kingdom, W12 0HS
Contact: Jeannette Davies    02083838070    Imperial.CRF@imperial.nhs.uk   
Principal Investigator: Gary Frost, BSc SRD PhD         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary Frost, BSc SRD PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01833689     History of Changes
Other Study ID Numbers: 13HH0549
Study First Received: April 12, 2013
Last Updated: January 22, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
glucose response
glycaemic index

ClinicalTrials.gov processed this record on August 27, 2014