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

Not Applicable

• Conditions: Inflammation; Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Tocotrienol-rich fraction; Dietary Supplement: Placebo

• Registration Number: NCT03532763
• Lead Sponsor: Malaysia Palm Oil Board

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.

Study Timeline

• Study Start: 2018-04-19
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-20
• Study First Posted: 2018-05-22
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocotrienol-rich fraction	Tocotrienol-rich fraction	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Malaysian Palm Oil Board; 🇲🇾 Kajang, Selangor, Malaysia