Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.
Six month supplementation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
Liver function test: Serum Alanine transaminase (ALT)
Change from baseline of liver enzymes
Time frame: week 0,12,24
Liver function test: Aspartate transaminase (AST)
Change from baseline of liver enzymes
Time frame: week 0,12,24
Liver function test:Blood gamma-glutamyl transferase (GGT)
change from baseline
Time frame: week 0,12,24
Liver function test:Blood albumin
change from baseline
Time frame: week 0,12,24
Liver function test: Blood bilirubin
change from baseline
Time frame: week 0,12,24
Hepatic steatosis
Change from baseline by ultrasound
Time frame: 0, 24 week
Weight
Change from baseline
Time frame: week 0,12,24
Waist circumference
Change from baseline
Time frame: week 0,12,24
Serum lipid profile
Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions
Time frame: week 0,12,24
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Blood glucose status
Change from baseline of HbA1c
Time frame: week 0,12,24
Inflammation
Change from baseline of CRP
Time frame: week 0,12,24
Kidney function test: serum creatinine
Change from baseline
Time frame: week 0,12,24
Kidney function test: Glomerular Filtration Rate(GFR)
Change from baseline
Time frame: week 0,12,24
Kidney function test: Blood Urea Nitrogen
Change from baseline
Time frame: week 0,12,24
Dietary supplement level in the blood
Determination of Fucoxanthin metabolite in plasma by LC-MS/MS
Time frame: week 0,6 or 12,24