Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
- Conditions
- Metabolism and Nutrition Disorders
- Interventions
- Other: Low-SDS extruded cerealsOther: High-SDS biscuit
- Registration Number
- NCT02538640
- Lead Sponsor
- Mondelēz International, Inc.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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Aged between 18-45 years.
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Non-smoker.
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BMI values between 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
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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.
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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).
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Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
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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)
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Able to fast for at least 10 hours the night before each test session
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Able to refrain from eating legumes and drinking alcohol the day before each test session.
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Subject covered by social security or covered by a similar system
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Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely tointerfere with metabolism or dietary habits
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Subject having given written consent to take part in the study.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low-SDS breakfast cereals Low-SDS extruded cereals 42 g of extruded cereals with no SDS and medium to high GI with a glass of water High-SDS biscuit High-SDS biscuit 50 g of moist biscuit with high-SDS content and low GI with a glass of water
- Primary Outcome Measures
Name Time Method Glycemic Response over 2 hours 2 hours iAUC of glycemia over 2 first hours of postprandial period
- Secondary Outcome Measures
Name Time Method Blood glucose kinetic 4 hours Postprandial kinetic of glycemia over the full postprandial period (analysis time by time)
Blood insulin peak 4 hours Maximal concentration and delta between maximum concentration and baseline value for insulinemia
Blood glucose peak 4 hours Maximal concentration and delta between maximum concentration and baseline value for glycemia
Glycemic response 4 hours 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
Insulinemic response 4 hours 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.
Blood insulin kinetic 4 hours Postprandial kinetic of insulinemia over the full postprandial period (analysis time by time)
Trial Locations
- Locations (1)
Human Nutrition Unit, The University of Sydney
🇦🇺Sydney, Australia