Oral Dietary Fucoxanthin Rich Supplement for Liver Health
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedStudy Start
First participant enrolled
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedAugust 14, 2018
July 1, 2018
1 year
July 2, 2018
August 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
Liver function test:Blood gamma-glutamyl transferase (GGT)
week 0,12,24
Liver function test:Blood albumin
week 0,12,24
Liver function test: Blood bilirubin
week 0,12,24
Hepatic steatosis
0, 24 week
Weight
week 0,12,24
- +8 more secondary outcomes
Study Arms (2)
Fucovital
EXPERIMENTALcapsules of a dietary supplement rich with fucoxanthin from microalgae extract
Placebo
PLACEBO COMPARATORcapsules of an edible oil
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Algatechnologies Ltd.lead
- Assaf-Harofeh Medical Centercollaborator
Related Publications (1)
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.
PMID: 33993853DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haim Shirin, Prof.
Director Institute of Gastroenterolgy, Liver Diseases and Nutrition
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2018
First Posted
August 10, 2018
Study Start
September 10, 2018
Primary Completion
September 10, 2019
Study Completion
December 10, 2019
Last Updated
August 14, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share