Cardiovascular Risk Factor, Inflammation
Conditions
Keywords
Inflammation, Tocotrienols, Cardiovascular disease
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTTocotrienol-rich fraction
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction
DIETARY_SUPPLEMENTPlacebo
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein
Sponsors
Universiti Putra Malaysia
Malaysia Palm Oil Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double blind, placebo-controlled, parallel
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 30-60 * Elevated plasma hs-CRP level of \> 1 mg/L \< 10 mg/L
Exclusion criteria
* Subjects with very high LDL-cholesterol ≥ 4.9 mmol/L * Subjects with very high hs-CRP level ≥ 10 mg/L * Pregnancy or lactation * Current use of vitamin E or corticosteroids * Significant hepatic and renal impairment * Fever, cold or infection during bleeding day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 0, 3, 6, 9 months | Change in high-sensitivity c-reactive protein (hs-CRP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers | 0, 3, 6, 9 months | Changes in IL-6, IL-1alpha, IL-1beta, TNF-alpha, E-selectin, ICAM-1, VCAM-1 |
| Thrombotic markers | 0, 3, 6, 9 months | Changes in PAI-1, D-dimer |
| Lipid profile | 0, 3, 6, 9 months | Changes in TC, LDL, HDL, ApoA1, ApoB |
| Glucose homeostasis | 0, 3, 6, 9 months | Changes in Glucose, insulin, c-peptide |
Countries
Malaysia
Contacts
Primary ContactJU YEN FU, PhD
Backup ContactPUVANESWARI MEGANATHAN, Msc
Outcome results
None listed