Oral Dietary Fucoxanthin Rich Supplement for Liver Health

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

Study Overview

• Status: Unknown
• Conditions: Non Alcoholic Fatty Liver
• Intervention / Treatment: Dietary supplement: FucoVital; Dietary supplement: Placebo

Detailed Description

Six month supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fucovital; capsules of a dietary supplement rich with fucoxanthin from microalgae extract	Dietary supplement: FucoVital; Microalgae oil extract; Other Names: fucoxanthin
Placebo Comparator: Placebo; capsules of an edible oil	Dietary supplement: FucoVital; Microalgae oil extract; Other Names: fucoxanthin; Dietary supplement: Placebo; Edible oil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Algatechnologies Ltd.
• Collaborators: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Haim Shirin, Prof., Director Institute of Gastroenterolgy, Liver Diseases and Nutrition

Publications and helpful links

General Publications

• Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2018
• Primary Completion (Anticipated): September 10, 2019
• Study Completion (Anticipated): December 10, 2019

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: non alcoholic fatty liver; fucoxanthin; microalgae
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Clinical protocol FUCO 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No