Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation

Conditions
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Inflammation, Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Tocotrienol-rich fraction
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double blind, placebo-controlled, parallel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocotrienol-rich fraction<br> | Dietary Supplement: Tocotrienol-rich fraction<br>* 1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction<br>* Other names: Tocovid Suprabio 200 mg;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Change in high-sensitivity c-reactive protein (hs-CRP) | 0, 3, 6, 9 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Tocotrienols, Cardiovascular disease