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

Primary Purpose

Inflammation, Cardiovascular Risk Factor

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Tocotrienol-rich fraction
Placebo
Sponsored by
Malaysia Palm Oil Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Inflammation, Tocotrienols, Cardiovascular disease

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Malaysian Palm Oil BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tocotrienol-rich fraction

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2018
Last Updated
August 27, 2018
Sponsor
Malaysia Palm Oil Board
Collaborators
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03532763
Brief Title
Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
Acronym
INTOC
Official Title
Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Cardiovascular Risk Factor
Keywords
Inflammation, Tocotrienols, Cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind, placebo-controlled, parallel
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tocotrienol-rich fraction
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Tocotrienol-rich fraction
Other Intervention Name(s)
Tocovid Suprabio 200 mg
Intervention Description
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein
Primary Outcome Measure Information:
Title
Inflammation
Description
Change in high-sensitivity c-reactive protein (hs-CRP)
Time Frame
0, 3, 6, 9 months
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
Changes in IL-6, IL-1alpha, IL-1beta, TNF-alpha, E-selectin, ICAM-1, VCAM-1
Time Frame
0, 3, 6, 9 months
Title
Thrombotic markers
Description
Changes in PAI-1, D-dimer
Time Frame
0, 3, 6, 9 months
Title
Lipid profile
Description
Changes in TC, LDL, HDL, ApoA1, ApoB
Time Frame
0, 3, 6, 9 months
Title
Glucose homeostasis
Description
Changes in Glucose, insulin, c-peptide
Time Frame
0, 3, 6, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JU YEN FU, PhD
Phone
+60126392394
Email
fujuyen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
PUVANESWARI MEGANATHAN, Msc
Phone
+60123348356
Email
mpuvaneswari@gmail.com
Facility Information:
Facility Name
Malaysian Palm Oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JU YEN FU, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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