Metabolic Disorder; Carbohydrate, Absorption, Intestine Clinical Trial
Official title:
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
| Verified date | September 2017 |
| Source | Mondelez International, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | University of Sydney | Sydney | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Mondelez International, Inc. | University of Sydney |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The plasma glucose peak value and the time for this latter will also be calculated. | 4 hours after food consumption | ||
| Other | The plasma insulin peak value and the time for this latter will also be calculated. | 4 hours after food consumption | ||
| Primary | 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 | 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 | ||
| Secondary | 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 |