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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-19

Study Completion Date

2019-06-30

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.

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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.

Conditions

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Inflammation Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blind, placebo-controlled, parallel

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tocotrienol-rich fraction

Group Type EXPERIMENTAL

Tocotrienol-rich fraction

Intervention Type DIETARY_SUPPLEMENT

1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein

Interventions

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Tocotrienol-rich fraction

1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Tocovid Suprabio 200 mg

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No