Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
NCT ID: NCT02650674
Last Updated: 2017-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-10-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Product A: NP-0148
Cereal product belVita Milk \& Cereals - High in SDS
Product A: NP-0148
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product B: NP-0149
Cereal product belVita Honey \& Nuts - High in SDS
Product B: NP-0149
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product C: NP-0150
Cereal product belVita Mixed Berry - High in SDS
Product C: NP-0150
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product D: NP-0151
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
Product D: NP-0151
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product E: NP-0152
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
Product E: NP-0152
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Glucose reference
Glucose solution performed on three occasions
Glucose solution
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times
Interventions
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Product A: NP-0148
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Glucose solution
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times
Product B: NP-0149
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product C: NP-0150
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product D: NP-0151
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Product E: NP-0152
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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University of Sydney
OTHER
Mondelēz International, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jennie Brand Miller
Role: PRINCIPAL_INVESTIGATOR
University of Sydney
Locations
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University of Sydney
Sydney, New South Wales, Australia
Countries
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Other Identifiers
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KBE043
Identifier Type: -
Identifier Source: org_study_id
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