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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02650674




Registration number
NCT02650674
Ethics application status
Date submitted
30/10/2015
Date registered
8/01/2016
Date last updated
14/09/2017

Titles & IDs
Public title
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Scientific title
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Secondary ID [1] 0 0
KBE043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Disorder 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Product A: NP-0148
Other interventions - Glucose solution
Other interventions - Product B: NP-0149
Other interventions - Product C: NP-0150
Other interventions - Product D: NP-0151
Other interventions - Product E: NP-0152

Experimental: Product A: NP-0148 - Cereal product belVita Milk & Cereals - High in SDS

Experimental: Product B: NP-0149 - Cereal product belVita Honey & Nuts - High in SDS

Experimental: Product C: NP-0150 - Cereal product belVita Mixed Berry - High in SDS

Experimental: Product D: NP-0151 - Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat

Experimental: Product E: NP-0152 - Cereal product Kellogg's Trésor Duo Choco - Low in SDS

Experimental: Glucose reference - Glucose solution performed on three occasions


Other interventions: Product A: NP-0148
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Other interventions: Glucose solution
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times

Other interventions: Product B: NP-0149
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Other interventions: Product C: NP-0150
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Other interventions: Product D: NP-0151
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Other interventions: Product E: NP-0152
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycaemic index values of five cereal products - Determination of GI in both Caucasian and Asian subjects
Timepoint [1] 0 0
2 hours after food consumption
Secondary outcome [1] 0 0
Glycaemic response assessed by the glycemic index (GI) values of five cereal products - Determination of GI in the global population
Timepoint [1] 0 0
2 hours after food consumption
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
2 hours after food consumption
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
2 hours after food consumption
Secondary outcome [4] 0 0
Glycaemic response assessed by the peak value of glycemia - This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Timepoint [4] 0 0
2 hours after food consumption
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
2 hours after food consumption
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
2 hours after food consumption
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
2 hours after food consumption
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
2 hours after food consumption
Secondary outcome [9] 0 0
Insulinaemic response assessed by the peak value of insulinemia - This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Timepoint [9] 0 0
2 hours after food consumption
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
2 hours after food consumption
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
2 hours after food consumption
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
2 hours after food consumption
Secondary outcome [13] 0 0
Kinetic of insulin / glucose over the 120 minutes - This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Timepoint [13] 0 0
2 hours after food consumption
Secondary outcome [14] 0 0
Peak value of insulin / glucose ratio - This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Timepoint [14] 0 0
2 hours after food consumption
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
2 hours after food consumption

Eligibility
Key inclusion criteria
- 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:

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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mondelez International, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five
Cereal Products in two different ethnic groups.
Trial website
https://clinicaltrials.gov/show/NCT02650674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennie Brand Miller
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications