Palm-derived tocotrienols have shown hepatoprotective effects in both animal and human studies. This study aims to investigate the effects of tocotrienols in hepatocellular lipid content using MRI. Non-alcoholic fatty liver disease (NAFLD) is a spectrum of diseases ranging from simple fatty liver (steatosis, NAFL) to non-alcoholic steatohepatitis (NASH) to cirrhosis. NASH is the accumulation of fat in liver cells accompanied with inflammation that can lead to the scarring of the liver. Prevention of liver fibrosis by early introduction of low risk interventions such as lifestyle modification, diet control and nutraceuticals may help circumvent long-term healthcare costs associated with management of chronic NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
170
Palm Tocotrienols complex
Placebo matching Tocovid Suprabio
KK Bandar Baru Air Itam
Pulau Pinang, Pulau Pinang, Malaysia
KK Jalan Perak
Pulau Pinang, Pulau Pinang, Malaysia
KK Bayan Baru
Pulau Pinang, Pulau Pinang, Malaysia
Hospital Seberang Jaya (CRC)
Seberang Jaya, Pulau Pinang, Malaysia
Reduction of Liver Fat (VLFF)
Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by Magnetic Resonance Imaging - Volumetric Liver Fat Fraction (MRI-VLFF)
Time frame: 12 months
Change in liver biochemistry
Between group difference in mean change of liver biochemistries (ALT, AST, GGT, AP, Bilirubin)
Time frame: 12 months
Change in liver fat fraction
Between group difference in mean change (%) from Baseline to 12 months in hepatic fat fraction by MRI-VLFF
Time frame: 12 months
Change in serum lipid profile
Between group difference in mean change of serum lipid profile
Time frame: 12 months
Occurrence of adverse events and serious adverse events
Between group difference in the occurrence of adverse events and serious adverse events.
Time frame: 12 months
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