Metabolic Disorder; Carbohydrate, Absorption, Intestine
Conditions
Keywords
glycemic & insulin response, SDS, cereal product, Nutrition
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.
Detailed description
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. It is a laboratory-based research study with an open cross-over design, including 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 2 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list.
Interventions
OTHERSandwich biscuit high in SDS
Consumption of the high SDS product (50g) alone with a glass of water
OTHERCo-extruded cereal low in SDS
Consumption of the low SDS product (48.3 g) alone with a glass of water
Sponsors
University of Sydney
Mondelēz International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products | 2 hours after food consumption |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 4 hours after food consumption |
| 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. | 4 hours after food consumption |
Other
| Measure | Time frame |
|---|---|
| The plasma glucose peak value and the time for this latter will also be calculated. | 4 hours after food consumption |
| The plasma insulin peak value and the time for this latter will also be calculated. | 4 hours after food consumption |
Countries
Australia
Outcome results
None listed