Non Alcoholic Fatty LiverNCT03625284
Oral Dietary Fucoxanthin Rich Supplement for Liver Health
A study testing FucoVital in people with Non Alcoholic Fatty Liver, run by Algatechnologies Ltd..
Trial summary
Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver
- What is being tested?
- FucoVital
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
Marina Beder contact
About this study
Blind, placebo-controlled study testing the hypothesis that oral dietary supplement rich with fucoxanthin will decrease biochemical clinical markers related to liver health.
Read the detailed description
Six month supplementation
- Conditions
- Non Alcoholic Fatty Liver
- Being tested
- Placebo, FucoVital
- Keywords
- fucoxanthin, microalgae, non alcoholic fatty liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Edible oil
FucoVitalDietary supplement
Also called fucoxanthin
Microalgae oil extract
| Study group | Role | What they receive |
|---|---|---|
| Fucovital | Experimental | capsules of a dietary supplement rich with fucoxanthin from microalgae extract Receives: Dietary Supplement: FucoVital |
| Placebo | Placebo comparator | capsules of an edible oil Receives: Dietary Supplement: Placebo; Dietary Supplement: FucoVital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function test: Serum Alanine transaminase (ALT)
Change from baseline of liver enzymes
Measured: week 0,12,24
Liver function test: Aspartate transaminase (AST)
Change from baseline of liver enzymes
Measured: week 0,12,24
Secondary outcomes (13)
Liver function test:Blood gamma-glutamyl transferase (GGT)
change from baseline
Measured: week 0,12,24
Liver function test:Blood albumin
change from baseline
Measured: week 0,12,24
Liver function test: Blood bilirubin
change from baseline
Measured: week 0,12,24
Hepatic steatosis
Change from baseline by ultrasound
Measured: 0, 24 week
Weight
Change from baseline
Measured: week 0,12,24
Waist circumference
Change from baseline
Measured: week 0,12,24
Serum lipid profile
Change from baseline total cholesterol, triglycerides, low density lipoprotein (LDL) (HDL) fractions
Measured: week 0,12,24
Blood glucose status
Change from baseline of HbA1c
Measured: week 0,12,24
Inflammation
Change from baseline of CRP
Measured: week 0,12,24
Kidney function test: serum creatinine
Change from baseline
Measured: week 0,12,24
Kidney function test: Glomerular Filtration Rate(GFR)
Change from baseline
Measured: week 0,12,24
Kidney function test: Blood Urea Nitrogen
Change from baseline
Measured: week 0,12,24
Dietary supplement level in the blood
Determination of Fucoxanthin metabolite in plasma by LC-MS/MS
Measured: week 0,6 or 12,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start10 Sep 2018 (estimated)
- Primary completion10 Sep 2019 (estimated)
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algatechnologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assaf-Harofeh Medical Center
- Responsible party
- Sponsor
- Investigators
- Haim Shirin, Prof., Principal investigator, Director Institute of Gastroenterolgy, Liver Diseases and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625284
- Sponsor's protocol ID
- Clinical protocol FUCO 02
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33993853
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dietary Fucoxanthin Rich Supplement for Liver Health
- ClinicalTrials.gov ID
- NCT03625284
- Acronym / sponsor ID
- Clinical protocol FUCO 02
- Conditions
- Non Alcoholic Fatty Liver
- Keywords
- fucoxanthin, microalgae, non alcoholic fatty liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Algatechnologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- 10 Sep 2018 (estimated)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fucovital | Experimental | Dietary Supplement: FucoVitalcapsules of a dietary supplement rich with fucoxanthin from microalgae extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: FucoVitalcapsules of an edible oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEdible oil | Dietary supplement | Placebo |
| FucoVitalAlso: fucoxanthinMicroalgae oil extract | Dietary supplement | Fucovital, Placebo |
Primary outcome
Liver function test: Serum Alanine transaminase (ALT)
Time frame: week 0,12,24
Change from baseline of liver enzymes
Liver function test: Aspartate transaminase (AST)
Time frame: week 0,12,24
Change from baseline of liver enzymes
13 secondary outcomes
Liver function test:Blood gamma-glutamyl transferase (GGT)
Time frame: week 0,12,24
Liver function test:Blood albumin
Time frame: week 0,12,24
Liver function test: Blood bilirubin
Time frame: week 0,12,24
Hepatic steatosis
Time frame: 0, 24 week
Weight
Time frame: week 0,12,24
Waist circumference
Time frame: week 0,12,24
Serum lipid profile
Time frame: week 0,12,24
Blood glucose status
Time frame: week 0,12,24
Inflammation
Time frame: week 0,12,24
Kidney function test: serum creatinine
Time frame: week 0,12,24
Kidney function test: Glomerular Filtration Rate(GFR)
Time frame: week 0,12,24
Kidney function test: Blood Urea Nitrogen
Time frame: week 0,12,24
Dietary supplement level in the blood
Time frame: week 0,6 or 12,24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 33993853Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Beder contact
Haim Shirin, Prof. principal investigator
Director Institute of Gastroenterolgy, Liver Diseases and Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing FucoVital in people with Non Alcoholic Fatty Liver, run by Algatechnologies Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tair Lapidot, Dr (+972548095209, tair@algatech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver function test: Serum Alanine transaminase (ALT) (time frame: week 0,12,24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.