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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02538640




Registration number
NCT02538640
Ethics application status
Date submitted
31/08/2015
Date registered
2/09/2015
Date last updated
1/11/2015

Titles & IDs
Public title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Scientific title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Secondary ID [1] 0 0
KBE040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - High-SDS biscuit
Other interventions - Low-SDS extruded cereals

Experimental: High-SDS biscuit - 50 g of moist biscuit with high-SDS content and low GI with a glass of water

Active Comparator: Low-SDS breakfast cereals - 42 g of extruded cereals with no SDS and medium to high GI with a glass of water


Other interventions: High-SDS biscuit
Consumption of the high-SDS product (50g) alone with a glass of water

Other interventions: Low-SDS extruded cereals
Consumption of the low-SDS product (42g) alone with a glass of water

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

Outcomes
Primary outcome [1] 0 0
Glycemic Response over 2 hours - iAUC of glycemia over 2 first hours of postprandial period
Timepoint [1] 0 0
2 hours
Secondary outcome [1] 0 0
Glycemic response - Postprandial changes in glycaemia over 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC[180-240]) following the intake of the test products will be analysed
Timepoint [1] 0 0
4 hours
Secondary outcome [2] 0 0
Blood glucose kinetic - Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)
Timepoint [2] 0 0
4 hours
Secondary outcome [3] 0 0
Insulinemic response - Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC [180-240]) following the intake of the test products will be analysed.
Timepoint [3] 0 0
4 hours
Secondary outcome [4] 0 0
Blood insulin kinetic - Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)
Timepoint [4] 0 0
4 hours
Secondary outcome [5] 0 0
Blood glucose peak - Maximal concentration and delta between maximum concentration and baseline value for glycemia
Timepoint [5] 0 0
4 hours
Secondary outcome [6] 0 0
Blood insulin peak - Maximal concentration and delta between maximum concentration and baseline value for insulinemia
Timepoint [6] 0 0
4 hours

Eligibility
Key inclusion criteria
- Aged between 18-45 years.

- Non-smoker.

- BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be
normal weight and the other half overweight.

- Ethnicity. Subjects should have the closest characteristics compared to the American
population. Not less than 75% but not more than 90% of the subjects should be
Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent.
The remaining subjects will be from other ethnic groups except from Australian
Aborigines.

- Healthy subjects with:

- Normal glucose tolerance (fasting blood glucose < 6.0 mmol/L during the first
test session and results of oral glucose tolerance test conducted within the last
30 days within recommendations (fasting blood glucose < 6.1 mmol/L, 120 minute
glucose < 8.9 mmol/L))

- 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 tointerfere 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)

- Subject from the Australian Aboriginal ethnicity.

- 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
Prevention
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)
Recruitment hospital [1] 0 0
Human Nutrition Unit, The 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 is a laboratory-based research study conducted in two parts. Open cross-over design. 2
test sessions per subject included in the study. It aims at determining the postprandial
blood glucose and insulin responses to the ingestion of cereal product differing by their SDS
content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
Trial website
https://clinicaltrials.gov/show/NCT02538640
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