Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Study Overview
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Brief Summary
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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
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Six month supplementation

Official Title
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Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Conditions
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Non Alcoholic Fatty Liver

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: FucoVital


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fucovital<br>capsules of a dietary supplement rich with fucoxanthin from microalgae extract | Dietary Supplement: FucoVital<br>* Microalgae oil extract<br>* Other names: fucoxanthin;|
| Placebo Comparator: Placebo<br>capsules of an edible oil | Dietary Supplement: Placebo<br>* Edible oil<br>Dietary Supplement: FucoVital<br>* Microalgae oil extract<br>* Other names: fucoxanthin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function test: Serum Alanine transaminase (ALT) | Change from baseline of liver enzymes | week 0,12,24 | 
| Liver function test: Aspartate transaminase (AST) | Change from baseline of liver enzymes | week 0,12,24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function test:Blood gamma-glutamyl transferase (GGT) | change from baseline | week 0,12,24 | 
| Liver function test:Blood albumin | change from baseline | week 0,12,24 | 
| Liver function test: Blood bilirubin | change from baseline | week 0,12,24 | 
| Hepatic steatosis | Change from baseline by ultrasound | 0, 24 week | 
| Weight | Change from baseline | week 0,12,24 | 
| Waist circumference | Change from baseline | week 0,12,24 | 
| Serum lipid profile | Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions | week 0,12,24 | 
| Blood glucose status | Change from baseline of HbA1c | week 0,12,24 | 
| Inflammation | Change from baseline of CRP | week 0,12,24 | 
| Kidney function test: serum creatinine | Change from baseline | week 0,12,24 | 
| Kidney function test: Glomerular Filtration Rate(GFR) | Change from baseline | week 0,12,24 | 
| Kidney function test: Blood Urea Nitrogen | Change from baseline | week 0,12,24 | 
| Dietary supplement level in the blood | Determination of Fucoxanthin metabolite in plasma by LC-MS/MS | week 0,6 or 12,24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fucoxanthin, microalgae, non alcoholic fatty liver