Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Algatechnologies

Status: Unknown

Conditions: Non Alcoholic Fatty Liver

Treatments: Dietary Supplement: Placebo; Dietary Supplement: FucoVital

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03625284

Clinical protocol FUCO 02

Details and patient eligibility

About

Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.

Full description

Six month supplementation

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Fucovital

Experimental group

Description:

capsules of a dietary supplement rich with fucoxanthin from microalgae extract

Treatment:

Dietary Supplement: FucoVital

Placebo

Placebo Comparator group

Description:

capsules of an edible oil

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: FucoVital