GlycaemiaNCT01870570
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers
A study testing Reference Glucose, Food Product A: Corn Flakes and Food Product B: Ginger Bread in people with Glycaemia and Insulinemia, run by Mondelēz International, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycaemia, Insulinemia
- What is being tested?
- Reference Glucose, Food Product A: Corn Flakes and Food Product B: Ginger Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2013to Dec 2013
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years inclusive.
- Non-smoker.
- BMI 19.0-25.0 kg/m2 inclusive.
- Healthy subjects with:
- Fasting plasma glucose < 5,6 mM (ADA criteria,2011)
- Insulin resistance index based on homeostasis model assessment (HOMA-IR) <1.70
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- Fasting lipids: triglyceride <1.70mmol/L, LDL-cholesterol<5.00 mmol/L and HDL-cholesterol >1.03mmol/L for males or >1.29mmol/L for females (IDF criteria for metabolic syndrome, 2006)
- Gamma-GT, AST and ALT <1.5 times the upper limit of normal (ULN)
- Complete blood count: Normal full blood count according to the investigator
- Systolic blood pressure <130 mmHg
- Diastolic blood pressure <85 mmHg
- Resting heart rate 50-90 beats per minutes (after 3 minutes rest).
- Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
- Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
- Able to fast for at least 10 hours the night before each test session.
- Able to refrain from eating legumes and drinking alcohol the day before each test session.
- Subject covered by social security or covered by a similar system
- Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
- Subject having given written consent to take part in the study
Who cannot join
- Following a restrictive or specific diet.
- Suffering from any inflammatory or metabolic diseases
- Suffering from mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
- Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
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- Subject having taken part in another clinical trial within the last week.
- Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
- Subject undergoing general anaesthesia in the month prior to inclusion.
- Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers
The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.
Read the detailed description
This study will be performed at 3 centers and 15 subjects will be recruited at each center.
- Conditions
- Glycaemia, Insulinemia
- Being tested
- Reference Glucose, Food Product A: Corn Flakes, Food Product B: Ginger Bread, Food Product C:Sandwiched Breakfast Biscuit, Food Product D: Crackers Nature
- Keywords
- Glycaemia, Insulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference GlucoseOther
Also called Glucose Standard (50g of Glucose)
Food Product A: Corn FlakesOther
Also called Corn Flakes
Food Product B: Ginger BreadOther
Also called Ginger Bread
Food Product C:Sandwiched Breakfast BiscuitOther
Also called Sandwiched Breakfast Biscuit
Food Product D: Crackers NatureOther
Also called Crackers Nature
Food Product E: Breakfast BiscuitOther
Also called Breakfast Biscuit
Food Product F: White BreadOther
Also called White Bread
| Study group | Role | What they receive |
|---|---|---|
| Reference Glucose | Other | Glucose Standard (50g of Glucose) Receives: Other: Reference Glucose |
| Food Product A: Corn Flakes | Experimental | Corn Flakes Receives: Other: Food Product A: Corn Flakes |
| Food Product B: Ginger Bread | Experimental | Ginger Bread Receives: Other: Food Product B: Ginger Bread |
| Food Product C:Sandwiched Breakfast Biscuit | Experimental | Sandwiched Breakfast Biscuit Receives: Other: Food Product C:Sandwiched Breakfast Biscuit |
| Food Product D: Crackers Nature | Experimental | Crackers Nature Receives: Other: Food Product D: Crackers Nature |
| Food Product E: Breakfast Biscuit | Experimental | Breakfast Biscuit Receives: Other: Food Product E: Breakfast Biscuit |
| Food Product F: White Bread | Experimental | White Bread Receives: Other: Food Product F: White Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
Measured: 0-120 minutes
Secondary outcomes (9)
Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products
Measured: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products
Measured: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products
Measured: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products
Measured: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products
Measured: 01-20 minutes
Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products
Measured: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products
Measured: 0-120 minutes
Determine the Intra-Laboratory Variability for the iAUC of Glycaemia
Measured: 0-120 minutes
Determine the Intra-Laboratory Variability of the iAUC of Insulinemia
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycaemiaStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, Glycemic Index Laboratories, Inc, University of Sydney
- Responsible party
- Sponsor
- Investigators
- David Gendre, Dr., Principal investigator, BioFortisThomas Wolever, Dr., Principal investigator, Glycemic Index Laboratories, IncJennie Brand Miller, Dr., Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870570
- Sponsor's protocol ID
- KBE019
- Status last verified
- Aug 2014
- First submitted
- 3 Jun 2013
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers
- ClinicalTrials.gov ID
- NCT01870570
- Acronym / sponsor ID
- KBE019
- Conditions
- Glycaemia, Insulinemia
- Keywords
- Glycaemia, Insulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, Glycemic Index Laboratories, Inc, University of Sydney
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jun 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 purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.
Detailed description
This study will be performed at 3 centers and 15 subjects will be recruited at each center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Reference Glucose | Other | Other: Reference GlucoseGlucose Standard (50g of Glucose) |
| Food Product A: Corn Flakes | Experimental | Other: Food Product A: Corn FlakesCorn Flakes |
| Food Product B: Ginger Bread | Experimental | Other: Food Product B: Ginger BreadGinger Bread |
| Food Product C:Sandwiched Breakfast Biscuit | Experimental | Other: Food Product C:Sandwiched Breakfast BiscuitSandwiched Breakfast Biscuit |
| Food Product D: Crackers Nature | Experimental | Other: Food Product D: Crackers NatureCrackers Nature |
| Food Product E: Breakfast Biscuit | Experimental | Other: Food Product E: Breakfast BiscuitBreakfast Biscuit |
| Food Product F: White Bread | Experimental | Other: Food Product F: White BreadWhite Bread |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Aged 18-35 years inclusive.
- Non-smoker.
- BMI 19.0-25.0 kg/m2 inclusive.
- Healthy subjects with:
- Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
Key exclusion criteria (10 listed)
- Following a restrictive or specific diet.
- Suffering from any inflammatory or metabolic diseases
- Suffering from mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
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 |
|---|---|---|
| Reference GlucoseAlso: Glucose Standard (50g of Glucose) | Other | Reference Glucose |
| Food Product A: Corn FlakesAlso: Corn Flakes | Other | Food Product A: Corn Flakes |
| Food Product B: Ginger BreadAlso: Ginger Bread | Other | Food Product B: Ginger Bread |
| Food Product C:Sandwiched Breakfast BiscuitAlso: Sandwiched Breakfast Biscuit | Other | Food Product C:Sandwiched Breakfast Biscuit |
| Food Product D: Crackers NatureAlso: Crackers Nature | Other | Food Product D: Crackers Nature |
| Food Product E: Breakfast BiscuitAlso: Breakfast Biscuit | Other | Food Product E: Breakfast Biscuit |
| Food Product F: White BreadAlso: White Bread | Other | Food Product F: White Bread |
Primary outcome
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
Time frame: 0-120 minutes
9 secondary outcomes
Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products
Time frame: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products
Time frame: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products
Time frame: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products
Time frame: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products
Time frame: 01-20 minutes
Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products
Time frame: 0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products
Time frame: 0-120 minutes
Determine the Intra-Laboratory Variability for the iAUC of Glycaemia
Time frame: 0-120 minutes
Determine the Intra-Laboratory Variability of the iAUC of Insulinemia
Time frame: 0-120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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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.
David Gendre, Dr. principal investigator
BioFortis
Thomas Wolever, Dr. principal investigator
Glycemic Index Laboratories, Inc
Jennie Brand Miller, Dr. principal investigator
University of Sydney
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference Glucose, Food Product A: Corn Flakes and Food Product B: Ginger Bread in people with Glycaemia and Insulinemia, run by Mondelēz International, Inc. at 3 sites in 3 countries.
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 19 inclusion and 10 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: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Canada, France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products (time frame: 0-120 minutes). 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 21 Aug 2014.