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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02538653




Registration number
NCT02538653
Ethics application status
Date submitted
31/08/2015
Date registered
2/09/2015
Date last updated
14/09/2017

Titles & IDs
Public title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
Scientific title
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
Secondary ID [1] 0 0
KBE042
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Disorder; Carbohydrate, Absorption, Intestine 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 - Sandwich biscuit high in SDS
Other interventions - Co-extruded cereal low in SDS

Experimental: Sandwich biscuits high in SDS - 50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.

Active Comparator: Co-extruded cereals low in SDS - 48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.


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

Other interventions: Co-extruded cereal low in SDS
Consumption of the low SDS product (48.3 g) alone with a glass of water
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
Timepoint [1] 0 0
2 hours after food consumption
Secondary outcome [1] 0 0
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 after food consumption
Secondary outcome [2] 0 0
Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), over 3 hours (iAUC [0-180]), 4 hours (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 [2] 0 0
4 hours after food consumption

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 < 6.0 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
Sex
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
Treatment
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
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
20
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 4-hours postprandial blood glucose and insulin responses
to the ingestion of cereal product differing by their SDS content.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02538653
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