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

Inflammation Clinical Trial

— INTOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532763
• Other study ID #: 28701
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: Malaysia Palm Oil Board
• Contact: JU YEN FU, PhD
• Phone: +60126392394
• Email: fujuyen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Inflammation

Intervention

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

Locations

Country	Name	City	State
Malaysia	Malaysian Palm Oil Board	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation	Change in high-sensitivity c-reactive protein (hs-CRP)	0, 3, 6, 9 months
Secondary	Inflammatory markers	Changes in IL-6, IL-1alpha, IL-1beta, TNF-alpha, E-selectin, ICAM-1, VCAM-1	0, 3, 6, 9 months
Secondary	Thrombotic markers	Changes in PAI-1, D-dimer	0, 3, 6, 9 months
Secondary	Lipid profile	Changes in TC, LDL, HDL, ApoA1, ApoB	0, 3, 6, 9 months
Secondary	Glucose homeostasis	Changes in Glucose, insulin, c-peptide	0, 3, 6, 9 months