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

August 27, 2018 updated by: Malaysia Palm Oil Board

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Recruiting
        • Malaysian Palm Oil Board
        • Contact:
          • JU YEN FU, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein
Experimental: Tocotrienol-rich fraction
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
Other Names:
  • Tocovid Suprabio 200 mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaysia Palm Oil Board

Collaborators

Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 20, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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