HealthyGINCT01833689
Glycaemic Index of Foods in Healthy Volunteers
A study testing food consumption in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- food consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5-27 kg/m2
- age 18-65 years
- healthy
Who cannot join
- diabetes
- chronic disease
- glucose impairment
- pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR/Wellcome Trust Imperial CRF
London, W12 0HS
Jeannette Davies, 02083838070, Imperial.CRF@imperial.nhs.uk
Gary Frost, BSc SRD PhD
About this study
Official title: Glycaemic Index Testing of Carbohydrate Containing Foods Using a Standardised Method
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- food consumption
- Keywords
- glucose response, glycaemic index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food consumptionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| food consumption: control | Placebo comparator | The control product will be 50g glucose powder dissolved in 250ml of water Receives: Dietary Supplement: food consumption |
| food consumption: product | Active comparator | The test food will provide 50g of available carbohydrate Receives: Dietary Supplement: food consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycaemic index
Measured: 1-2 months depending on product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Frost, BSc SRD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833689
- Sponsor's protocol ID
- 13HH0549
- Acronym
- GI
- Status last verified
- Aug 2023
- First submitted
- 12 Apr 2013
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Index Testing of Carbohydrate Containing Foods Using a Standardised Method
- ClinicalTrials.gov ID
- NCT01833689
- Acronym / sponsor ID
- GI / 13HH0549
- Conditions
- Healthy
- Keywords
- glucose response, glycaemic index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| food consumption: control | Placebo comparator | Dietary Supplement: food consumptionThe control product will be 50g glucose powder dissolved in 250ml of water |
| food consumption: product | Active comparator | Dietary Supplement: food consumptionThe test food will provide 50g of available carbohydrate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 18.5-27 kg/m2
- age 18-65 years
- healthy
Key exclusion criteria (4 listed)
- diabetes
- chronic disease
- glucose impairment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food consumptionReference 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. | Dietary supplement | food consumption: control, food consumption: product |
Primary outcome
glycaemic index
Time frame: 1-2 months depending on product
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Frost, BSc SRD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food consumption in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gary Frost, BSc SRD PhD (020 8383 8037, g.frost@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycaemic index (time frame: 1-2 months depending on product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.