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Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Primary Purpose

Non Alcoholic Fatty Liver

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Placebo

FucoVital

About this trial

This is an interventional prevention trial for Non Alcoholic Fatty Liver focused on measuring fucoxanthin, microalgae, non alcoholic fatty liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fucovital

Placebo

Arm Description

capsules of a dietary supplement rich with fucoxanthin from microalgae extract

capsules of an edible oil

Outcomes

Primary Outcome Measures

Liver function test: Serum Alanine transaminase (ALT)

Change from baseline of liver enzymes

Liver function test: Aspartate transaminase (AST)

Change from baseline of liver enzymes

Secondary Outcome Measures

Liver function test:Blood gamma-glutamyl transferase (GGT)

change from baseline

Liver function test:Blood albumin

change from baseline

Liver function test: Blood bilirubin

change from baseline

Hepatic steatosis

Change from baseline by ultrasound

Weight

Change from baseline

Waist circumference

Change from baseline

Serum lipid profile

Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions

Blood glucose status

Change from baseline of HbA1c

Inflammation

Change from baseline of CRP

Kidney function test: serum creatinine

Change from baseline

Kidney function test: Glomerular Filtration Rate(GFR)

Change from baseline

Kidney function test: Blood Urea Nitrogen

Change from baseline

Dietary supplement level in the blood

Determination of Fucoxanthin metabolite in plasma by LC-MS/MS

Full Information

NCT ID

NCT03625284

First Posted

July 2, 2018

Last Updated

August 12, 2018

Sponsor

Algatechnologies Ltd.

Collaborators

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03625284

Brief Title

Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Official Title

Oral Dietary Fucoxanthin Rich Supplement for Liver Health

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 10, 2018 (Anticipated)

Primary Completion Date

September 10, 2019 (Anticipated)

Study Completion Date

December 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Algatechnologies Ltd.

Collaborators

Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Alcoholic Fatty Liver

Keywords

fucoxanthin, microalgae, non alcoholic fatty liver

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fucovital

Arm Type

Experimental

Arm Description

capsules of a dietary supplement rich with fucoxanthin from microalgae extract

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

capsules of an edible oil

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Edible oil

Intervention Type

Dietary Supplement

Intervention Name(s)

FucoVital

Other Intervention Name(s)

fucoxanthin

Intervention Description

Microalgae oil extract

Primary Outcome Measure Information:

Title

Liver function test: Serum Alanine transaminase (ALT)

Description

Change from baseline of liver enzymes

Time Frame

week 0,12,24

Title

Liver function test: Aspartate transaminase (AST)

Description

Change from baseline of liver enzymes

Time Frame

week 0,12,24

Secondary Outcome Measure Information:

Title

Liver function test:Blood gamma-glutamyl transferase (GGT)

Description

change from baseline

Time Frame

week 0,12,24

Title

Liver function test:Blood albumin

Description

change from baseline

Time Frame

week 0,12,24

Title

Liver function test: Blood bilirubin

Description

change from baseline

Time Frame

week 0,12,24

Title

Hepatic steatosis

Description

Change from baseline by ultrasound

Time Frame

0, 24 week

Title

Weight

Description

Change from baseline

Time Frame

week 0,12,24

Title

Waist circumference

Description

Change from baseline

Time Frame

week 0,12,24

Title

Serum lipid profile

Description

Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions

Time Frame

week 0,12,24

Title

Blood glucose status

Description

Change from baseline of HbA1c

Time Frame

week 0,12,24

Title

Inflammation

Description

Change from baseline of CRP

Time Frame

week 0,12,24

Title

Kidney function test: serum creatinine

Description

Change from baseline

Time Frame

week 0,12,24

Title

Kidney function test: Glomerular Filtration Rate(GFR)

Description

Change from baseline

Time Frame

week 0,12,24

Title

Kidney function test: Blood Urea Nitrogen

Description

Change from baseline

Time Frame

week 0,12,24

Title

Dietary supplement level in the blood

Description

Determination of Fucoxanthin metabolite in plasma by LC-MS/MS

Time Frame

week 0,6 or 12,24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tair Lapidot, Dr

Phone

+972548095209

tair@algatech.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Beder

marinabe@asaf.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haim Shirin, Prof.

Organizational Affiliation

Director Institute of Gastroenterolgy, Liver Diseases and Nutrition

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33993853

Citation

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.

Results Reference

derived

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Oral Dietary Fucoxanthin Rich Supplement for Liver Health

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