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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532763
Recruitment Status : Unknown
Verified August 2018 by Malaysia Palm Oil Board.
Recruitment status was:  Recruiting
First Posted : May 22, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Universiti Putra Malaysia
Information provided by (Responsible Party):
Malaysia Palm Oil Board

Study Description
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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.


Condition or disease Intervention/treatment Phase
Inflammation Cardiovascular Risk Factor Dietary Supplement: Tocotrienol-rich fraction Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double blind, placebo-controlled, parallel
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
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 Name: Tocovid Suprabio 200 mg
Placebo Comparator: Placebo Dietary Supplement: Placebo
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein


Outcome Measures
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Primary Outcome Measures :
  1. Inflammation [ Time Frame: 0, 3, 6, 9 months ]
    Change in high-sensitivity c-reactive protein (hs-CRP)


Secondary Outcome Measures :
  1. 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

  2. Thrombotic markers [ Time Frame: 0, 3, 6, 9 months ]
    Changes in PAI-1, D-dimer

  3. Lipid profile [ Time Frame: 0, 3, 6, 9 months ]
    Changes in TC, LDL, HDL, ApoA1, ApoB

  4. Glucose homeostasis [ Time Frame: 0, 3, 6, 9 months ]
    Changes in Glucose, insulin, c-peptide


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532763


Contacts
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Contact: JU YEN FU, PhD +60126392394 fujuyen@gmail.com
Contact: PUVANESWARI MEGANATHAN, Msc +60123348356 mpuvaneswari@gmail.com

Locations
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Malaysia
Malaysian Palm Oil Board Recruiting
Kajang, Selangor, Malaysia, 43000
Contact: JU YEN FU, PhD         
Sponsors and Collaborators
Malaysia Palm Oil Board
Universiti Putra Malaysia
More Information
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Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT03532763    
Other Study ID Numbers: 28701
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malaysia Palm Oil Board:
Inflammation
Tocotrienols
Cardiovascular disease
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Tocotrienols
Vitamin E
Tocopherols
Tocovid
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients