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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
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The objective of this study is to address the anti-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation.
It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects.
A double-blind, randomized, placebo-controlled, parallel study comparing the effect of tocotrienols vs. placebo will be conducted in subjects with moderately elevated inflammation. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily or placebo for 6 months. Fasting blood samples will be collected at baseline, 3 months, 6 months. A post-study fasting blood sample will be collected at 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocotrienol-rich fraction | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol-rich fraction | Dietary Supplement | 1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Change in high-sensitivity c-reactive protein (hs-CRP) | 0, 3, 6, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | Changes in IL-6, IL-1alpha, IL-1beta, TNF-alpha, E-selectin, ICAM-1, VCAM-1 | 0, 3, 6, 9 months |
| Thrombotic markers | Changes in PAI-1, D-dimer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JU YEN FU, PhD | Contact | +60126392394 | fujuyen@gmail.com | |
| PUVANESWARI MEGANATHAN, Msc | Contact | +60123348356 | mpuvaneswari@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malaysian Palm Oil Board | Recruiting | Kajang | Selangor | 43000 | Malaysia |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, double blind, placebo-controlled, parallel
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| Placebo | Dietary Supplement | 1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein |
|
| 0, 3, 6, 9 months |
| Lipid profile | Changes in TC, LDL, HDL, ApoA1, ApoB | 0, 3, 6, 9 months |
| Glucose homeostasis | Changes in Glucose, insulin, c-peptide | 0, 3, 6, 9 months |