Oral Dietary Fucoxanthin Rich Supplement for Liver Health

NCT ID: NCT03625284

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-12-10

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

Conditions

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Non Alcoholic Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fucovital

capsules of a dietary supplement rich with fucoxanthin from microalgae extract

Group Type EXPERIMENTAL

FucoVital

Intervention Type DIETARY_SUPPLEMENT

Microalgae oil extract

Placebo

capsules of an edible oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Edible oil

FucoVital

Intervention Type DIETARY_SUPPLEMENT

Microalgae oil extract

Interventions

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Placebo

Edible oil

Intervention Type DIETARY_SUPPLEMENT

FucoVital

Microalgae oil extract

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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fucoxanthin

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role collaborator

Algatechnologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haim Shirin, Prof.

Role: PRINCIPAL_INVESTIGATOR

Director Institute of Gastroenterolgy, Liver Diseases and Nutrition

Central Contacts

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Tair Lapidot, Dr

Role: CONTACT

+972548095209

Marina Beder

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 33993853 (View on PubMed)

Other Identifiers

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Clinical protocol FUCO 02

Identifier Type: -

Identifier Source: org_study_id

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