Non Alcoholic Fatty Liver
Conditions
Keywords
fucoxanthin, microalgae, non alcoholic fatty liver
Brief summary
Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.
Detailed description
Six month supplementation
Interventions
DIETARY_SUPPLEMENTPlacebo
Edible oil
DIETARY_SUPPLEMENTFucoVital
Microalgae oil extract
Sponsors
Assaf-Harofeh Medical Center
Algatechnologies Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults \> 18 years * Willing to sign an informed consent to participate in the study. * Non-smokers. * Blood results above the normal range in hepatic function testing consisting of panels containing ALT, AST, ALP, total bilirubin and albumin and abdominal ultrasonography. * Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome.
Exclusion criteria
* Pregnancy. * Presence of gastrointestinal or mental disorders, diabetes mellitus, alcohol abuse, weight-loss treatment, bariatric surgery, unusual diets (vegetarian, vegan), daily usage of antioxidants dietary supplements at the last 4 months (for subjects in stage 2 of the study). * Serious medical conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver function test: Serum Alanine transaminase (ALT) | week 0,12,24 | Change from baseline of liver enzymes |
| Liver function test: Aspartate transaminase (AST) | week 0,12,24 | Change from baseline of liver enzymes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver function test: Blood bilirubin | week 0,12,24 | change from baseline |
| Hepatic steatosis | 0, 24 week | Change from baseline by ultrasound |
| Weight | week 0,12,24 | Change from baseline |
| Waist circumference | week 0,12,24 | Change from baseline |
| Serum lipid profile | week 0,12,24 | Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions |
| Liver function test:Blood gamma-glutamyl transferase (GGT) | week 0,12,24 | change from baseline |
| Inflammation | week 0,12,24 | Change from baseline of CRP |
| Kidney function test: serum creatinine | week 0,12,24 | Change from baseline |
| Kidney function test: Glomerular Filtration Rate(GFR) | week 0,12,24 | Change from baseline |
| Kidney function test: Blood Urea Nitrogen | week 0,12,24 | Change from baseline |
| Dietary supplement level in the blood | week 0,6 or 12,24 | Determination of Fucoxanthin metabolite in plasma by LC-MS/MS |
| Blood glucose status | week 0,12,24 | Change from baseline of HbA1c |
| Liver function test:Blood albumin | week 0,12,24 | change from baseline |
Contacts
Primary ContactTair Lapidot, Dr
Backup ContactMarina Beder
Outcome results
None listed