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| Name | Class |
|---|---|
| University of Malaya | OTHER |
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Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
A randomised, double-blind, crossover trial will be undertaken to test the acute effects of supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to attend during postprandial period and these occasions will be separated by at least one week. On the day preceding the postprandial high fat meal challenge, subjects will be asked to avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects will be provided with a standardised low fat meal (containing < 10 g fat) on the day preceding the postprandial study days to consume as their evening meal. They will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10 pm. Fasting blood samples will be collected on the next day and subjects will then consume the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood samples will be collected at regular intervals for up to 6 hours postprandially.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg gd-TRF | Experimental |
| |
| 400 mg gd-TRF | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma delta TRF | Dietary Supplement | 50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake. |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide | 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity (insulin, glucose) | 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min | |
| Non-esterified fatty acid (NEFA) | 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Teng Kim Tiu, PhD | Malaysia Palm Oil Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malaysia Palm Oil Board | Kajang | Selangor | 43000 | Malaysia | ||
| Malaysian Palm Oil Board (MPOB) |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | 50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake. |
|
| Serum triglycerides (TAG) |
| 0, 60, 120, 180, 240, 300, 360 min |
| Inflammatory markers (IL-6, IL-1β, TNF-α) | 0, 120, 240, 360 min |
| PBMC nuclear factor-κappa B (NF-κB) | 0, 240, 360 min |
| Kajang |
| Selangor |
| 43000 |
| Malaysia |