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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 30, 2019

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 Supplement: Tocotrienol-rich fraction
    • 1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction
  • Dietary Supplement: Placebo
    • 1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein

Arms, Groups and Cohorts

  • Experimental: Tocotrienol-rich fraction
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Inflammation
    • Time Frame: 0, 3, 6, 9 months
    • Change in high-sensitivity c-reactive protein (hs-CRP)

Secondary Measures

  • Inflammatory markers
    • Time Frame: 0, 3, 6, 9 months
    • Changes in IL-6, IL-1alpha, IL-1beta, TNF-alpha, E-selectin, ICAM-1, VCAM-1
  • Thrombotic markers
    • Time Frame: 0, 3, 6, 9 months
    • Changes in PAI-1, D-dimer
  • Lipid profile
    • Time Frame: 0, 3, 6, 9 months
    • Changes in TC, LDL, HDL, ApoA1, ApoB
  • Glucose homeostasis
    • Time Frame: 0, 3, 6, 9 months
    • Changes in Glucose, insulin, c-peptide

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Malaysia Palm Oil Board
  • Collaborator
    • Universiti Putra Malaysia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • JU YEN FU, PhD, +60126392394, fujuyen@gmail.com

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