Metabolic DisorderNCT02650674
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
A study testing Product A: NP-0148, Glucose solution and Product B: NP-0149 in people with Metabolic Disorder, run by Mondelēz International, Inc. at 1 site in Australia.
Trial summary
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorder
- What is being tested?
- Product A: NP-0148, Glucose solution and Product B: NP-0149
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2015to Apr 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-45 years.
- Non-smoker.
- BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
- Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
- Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
- Healthy subjects with:
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- Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal 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 diet.
- Family history of Diabetes Mellitus or obesity
- Suffering from any clinical, physical or mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
- Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
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- Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
- 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
1 site in 1 country.
About this study
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.
Read the detailed description
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.
- Conditions
- Metabolic Disorder
- Being tested
- Product A: NP-0148, Glucose solution, Product B: NP-0149, Product C: NP-0150, Product D: NP-0151
- Keywords
- glycemic & insulin response, SDS, cereal product, Nutrition, Carbohydrate, Absorption, Intestine
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product A: NP-0148Other
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Glucose solutionOther
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times
Product B: NP-0149Other
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product C: NP-0150Other
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product D: NP-0151Other
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product E: NP-0152Other
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
| Study group | Role | What they receive |
|---|---|---|
| Product A: NP-0148 | Experimental | Cereal product belVita Milk \& Cereals - High in SDS Receives: Other: Product A: NP-0148 |
| Product B: NP-0149 | Experimental | Cereal product belVita Honey \& Nuts - High in SDS Receives: Other: Product B: NP-0149 |
| Product C: NP-0150 | Experimental | Cereal product belVita Mixed Berry - High in SDS Receives: Other: Product C: NP-0150 |
| Product D: NP-0151 | Experimental | Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat Receives: Other: Product D: NP-0151 |
| Product E: NP-0152 | Experimental | Cereal product Kellogg's Trésor Duo Choco - Low in SDS Receives: Other: Product E: NP-0152 |
| Glucose reference | Experimental | Glucose solution performed on three occasions Receives: Other: Glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic index values of five cereal products
Determination of GI in both Caucasian and Asian subjects
Measured: 2 hours after food consumption
Secondary outcomes (15)
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Determination of GI in the global population
Measured: 2 hours after food consumption
Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Glycaemic response assessed by the peak value of glycemia
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Insulinaemic response assessed by the peak value of insulinemia
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Insulin / glucose ratio (II/GI) evaluation of five cereal products
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Kinetic of insulin / glucose over the 120 minutes
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Peak value of insulin / glucose ratio
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Delta peak value between baseline and peak values of insulin / glucose ratio
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Measured: 2 hours after food consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisorderStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Sydney
- Responsible party
- Sponsor
- Investigators
- Jennie Brand Miller, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650674
- Sponsor's protocol ID
- KBE043
- Status last verified
- Sep 2017
- First submitted
- 30 Oct 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
- ClinicalTrials.gov ID
- NCT02650674
- Acronym / sponsor ID
- KBE043
- Conditions
- Metabolic Disorder
- Keywords
- glycemic & insulin response, SDS, cereal product, Nutrition, Carbohydrate, Absorption, Intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Sydney
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Jan 2016 (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.
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.
Detailed description
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Product A: NP-0148 | Experimental | Other: Product A: NP-0148Cereal product belVita Milk \& Cereals - High in SDS |
| Product B: NP-0149 | Experimental | Other: Product B: NP-0149Cereal product belVita Honey \& Nuts - High in SDS |
| Product C: NP-0150 | Experimental | Other: Product C: NP-0150Cereal product belVita Mixed Berry - High in SDS |
| Product D: NP-0151 | Experimental | Other: Product D: NP-0151Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat |
| Product E: NP-0152 | Experimental | Other: Product E: NP-0152Cereal product Kellogg's Trésor Duo Choco - Low in SDS |
| Glucose reference | Experimental | Other: Glucose solutionGlucose solution performed on three occasions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Aged between 18-45 years.
- Non-smoker.
- BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
- Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
- Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
Key exclusion criteria (11 listed)
- Following a restrictive diet.
- Family history of Diabetes Mellitus or obesity
- Suffering from any clinical, physical or mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
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 |
|---|---|---|
| Product A: NP-0148Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water. | Other | Product A: NP-0148 |
| Glucose solutionGlucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times | Other | Glucose reference |
| Product B: NP-0149Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water. | Other | Product B: NP-0149 |
| Product C: NP-0150Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water. | Other | Product C: NP-0150 |
| Product D: NP-0151Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water. | Other | Product D: NP-0151 |
| Product E: NP-0152Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water. | Other | Product E: NP-0152 |
Primary outcome
Glycaemic index values of five cereal products
Time frame: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
15 secondary outcomes
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Time frame: 2 hours after food consumption
Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
Time frame: 2 hours after food consumption
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
Time frame: 2 hours after food consumption
Glycaemic response assessed by the peak value of glycemia
Time frame: 2 hours after food consumption
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
Time frame: 2 hours after food consumption
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
Time frame: 2 hours after food consumption
Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
Time frame: 2 hours after food consumption
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
Time frame: 2 hours after food consumption
Insulinaemic response assessed by the peak value of insulinemia
Time frame: 2 hours after food consumption
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
Time frame: 2 hours after food consumption
Insulin / glucose ratio (II/GI) evaluation of five cereal products
Time frame: 2 hours after food consumption
Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
Time frame: 2 hours after food consumption
Kinetic of insulin / glucose over the 120 minutes
Time frame: 2 hours after food consumption
Peak value of insulin / glucose ratio
Time frame: 2 hours after food consumption
Delta peak value between baseline and peak values of insulin / glucose ratio
Time frame: 2 hours after food consumption
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 14 Sep 2017.
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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.
Jennie Brand Miller principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A: NP-0148, Glucose solution and Product B: NP-0149 in people with Metabolic Disorder, run by Mondelēz International, Inc. at 1 site in Australia.
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 14 inclusion and 11 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 14 Sep 2017. 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 Australia. 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?
Glycaemic index values of five cereal products (time frame: 2 hours after food consumption). 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 Sep 2017.