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| Name | Class |
|---|---|
| Taylor's University | OTHER |
| National University of Malaysia | OTHER |
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The aim of this clinical trial is to investigate the effects of the meals moderated by fat and carbohydrate (CHO) quality along with varying macronutrient distribution (CHO: fat) on gut physiology and metabolic outcomes using the human postprandial model with healthy subjects.
The main question[s] it aims to answer are:
The study's objectives will be tested via a crossover study with 18 diet rotations separated by minimum one week washout period. All recruited subjects will be assigned into, 9 HGI and 9 LGI diet rotations. The study design will be a cross-over trial with the same subjects undergoing all arms of the diet rotations. The subjects will be blinded to the test fats used for each rotation. Body weight measurements will be recorded before each postprandial challenge to minimise weight fluctuations between the test rotations.
Study procedures
Oral glucose tolerance test (OGTT) Sessions
Prior and end of the test meal rotations, subjects will undergo oral glucose tolerance test (OGTT) with a glucose reference drink at 2 random sessions without MRI investigation at Taylor's University or Hospital Cancelor Tuanku Muhriz (HCTM), to get an average value for the plasma glucose and insulin standards for each subject. The glucose reference drink composition will be 50g of anhydrous glucose mixed with 250mL of room temperature water. Blood samples will be collected sequentially at 0, 15, 30, 60, 90,120 and 180 minutes.
Test meal sessions
During each postprandial test meal rotations, subjects will consume test meals followed by MRI scans at the MRI center at Hospital Cancelor Tuanku Muhriz(HCTM). For scheduled session, Subjects will be advised to refrain from strenuous physical activity, high calorie or fast-food, supplements and coffee intake for 24 hours preceding each postprandial event. Subjects will be at the clinical center at 7:30 and 8:30a.m, following a 12-hour overnight fast. Upon arrival at the centre, subjects will rest for 10min, followed by body weight, blood pressure and self-monitoring of blood glucose (SBMG) measurements. Subsequently, blood samples will be drawn for metabolic investigations as per study objectives. Sequential postprandial MRI scans before and after test meal intake at 0(fasting), 15, 30, 60, 90, 120, 180, 240 and 300 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIET FIJA | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil A served together with 250 milliliter of plain water. |
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| DIET F1JB | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F2JA | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F2JB | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F3JA | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F3JB | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIJA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Lipemia | To determine the postprandial changes in triacylglyceride (TAG) | 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals |
| Glycemia | To determine the postprandial changes of glucose | 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying | To determine the postprandial changes in half emptying time | 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals |
| Gut hormone | To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP) |
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Inclusion Criteria:
Healthy subjects, (n=12-14) without history of chronic disease(s) with body mass index (BMI) between 18.5-25.0 kg/m2 and normal fasting blood glucose status [<5.4 mmol/L] will be enrolled into the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gowri Nagapan | Malaysia Palm Oil Board | Principal Investigator |
| Tilakavati Dr Karupaiah, PhD | School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Faculty of Medicine, Hospital Cancelor Tuanku Mukhriz, Universiti Kebangsaan Malaysia | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
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1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F4JA | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F4JB | Experimental | 1 portion of HGI (high glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F1PA | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F1PB | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F2PA | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F2PB | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F3PA | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F3PB | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil B served with 250 milliliter of plain water. |
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| DIET F4PA | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil A served with 250 milliliter of plain water. |
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| DIET F4PB | Experimental | 1 portion of LGI (low glycemic index) fried rice, fried with oil B served together with 250 milliliter of plain water. |
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| HGI PLAIN RICE | Placebo Comparator | 1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water. |
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| LGI PLAIN RICE | Placebo Comparator | 1 portion of HGI (low glycemic index) plain rice served with 250 milliliters of plain water. |
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| F1JB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F2JA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F2JB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F3JA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F3JB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after the consumption of test meal. |
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| F4JA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F4JB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F1PA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F1PB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F2PA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F2PB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F3PA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F3PB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F4PA | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| F4PB | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| HGI PLAIN RICE | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| LGI PLAIN RICE | Other | A 5-hour postprandial feeding intervention with 1-weeks washout in between. MRI scan and blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal. |
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| 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals |
| Malaysian Palm Oil Board | Kajang | Selangor | 43000 | Malaysia |
| School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University | Subang Jaya | Selangor | 47500 | Malaysia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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