NCT03532763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

April 26, 2018

Last Update Submit

August 27, 2018

Conditions

InflammationCardiovascular Risk Factor

Keywords

InflammationTocotrienolsCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Inflammation

    Change in high-sensitivity c-reactive protein (hs-CRP)

    0, 3, 6, 9 months

Secondary Outcomes (4)

  • Inflammatory markers

    0, 3, 6, 9 months

  • Thrombotic markers

    0, 3, 6, 9 months

  • Lipid profile

    0, 3, 6, 9 months

  • Glucose homeostasis

    0, 3, 6, 9 months

Study Arms (2)

Tocotrienol-rich fraction

EXPERIMENTAL
Dietary Supplement: Tocotrienol-rich fraction

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Tocotrienol-rich fractionDIETARY_SUPPLEMENT

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

Also known as: Tocovid Suprabio 200 mg
Tocotrienol-rich fraction
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-60
  • Elevated plasma hs-CRP level of \> 1 mg/L \< 10 mg/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

RECRUITING

MeSH Terms

Conditions

InflammationCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

JU YEN FU, PhD

CONTACT

+60126392394fujuyen@gmail.com

PUVANESWARI MEGANATHAN, Msc

CONTACT

+60123348356mpuvaneswari@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, double blind, placebo-controlled, parallel
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 22, 2018

Study Start

April 19, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

MY(1)