Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Not Applicable

• Conditions: Non Alcoholic Fatty Liver
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: FucoVital

• Registration Number: NCT03625284
• Lead Sponsor: Algatechnologies Ltd.

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

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-10
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14
• Study Start: 2018-09-10
• Primary Completion: 2019-09-10
• Study Completion: 2019-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	FucoVital	capsules of an edible oil
Fucovital	FucoVital	capsules of a dietary supplement rich with fucoxanthin from microalgae extract
Placebo	Placebo	capsules of an edible oil

Primary Outcome Measures

Name	Time	Method
Liver function test: Aspartate transaminase (AST)	week 0,12,24	Change from baseline of liver enzymes
Liver function test: Serum Alanine transaminase (ALT)	week 0,12,24	Change from baseline of liver enzymes

Secondary Outcome Measures

Name	Time	Method
Liver function test:Blood gamma-glutamyl transferase (GGT)	week 0,12,24	change from baseline
Liver function test:Blood albumin	week 0,12,24	change from baseline
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
Blood glucose status	week 0,12,24	Change from baseline of HbA1c
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