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

Malaysia Palm Oil Board

Status: Unknown

Conditions: Inflammation; Cardiovascular Risk Factor

Treatments: Dietary Supplement: Tocotrienol-rich fraction; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03532763

28701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Tocotrienol-rich fraction

Experimental group

Treatment:

Dietary Supplement: Tocotrienol-rich fraction

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo