Non-alcoholic Fatty Liver DiseaseNCT02875392
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
A study testing 275mg Oligo Fucoidan + 275mg HS Fucoxanthin in people with Non-alcoholic Fatty Liver Disease, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- 275mg Oligo Fucoidan + 275mg HS Fucoxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).
Who cannot join
- Patients were allergic to seafood.
- Patients who take Vitamin E or Pioglitazone.
Trial locations and contacts
1 site in 1 country.
About this study
Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
Read the detailed description
Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness. The strongest fucoidan among all seaweed for inhibiting cancer cells is in Okinawa Japanese waters. For chemically speaking, the major components for fucoidan consisted of mainly fucose which is a kind of polysaccharide with strong biological activity. However, patients need to take actual fucoidan in order to reach the best effectiveness for inhibiting cancer cell.
Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- 275mg Oligo Fucoidan + 275mg HS Fucoxanthin, placebo pills
- 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.
275mg Oligo Fucoidan + 275mg HS FucoxanthinOther
Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
placebo pillsOther
taking placebo pills as if patients are under treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fucoidan use | Experimental | FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper) Receives: Other: 275mg Oligo Fucoidan + 275mg HS Fucoxanthin |
| placebo pills | Placebo comparator | placebo capsule 6 per day (before breakfast and supper) Receives: Other: placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALT Index
Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.
Measured: 6 months
Change in AST Index
Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation
Measured: 6 months
Change in HbA1c
Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Shung Wu, Doctor, Study director, Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875392
- Sponsor's protocol ID
- N201605071
- Status last verified
- Jul 2016
- First submitted
- 5 Aug 2016
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02875392
- Acronym / sponsor ID
- N201605071
- Conditions
- Non-alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 17 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
Detailed description
Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness. The strongest fucoidan among all seaweed for inhibiting cancer cells is in Okinawa Japanese waters. For chemically speaking, the major components for fucoidan consisted of mainly fucose which is a kind of polysaccharide with strong biological activity. However, patients need to take actual fucoidan in order to reach the best effectiveness for inhibiting cancer cell.
Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fucoidan use | Experimental | Other: 275mg Oligo Fucoidan + 275mg HS FucoxanthinFucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper) |
| placebo pills | Placebo comparator | Other: placebo pillsplacebo capsule 6 per day (before breakfast and supper) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).
Key exclusion criteria (2 listed)
- Patients were allergic to seafood.
- Patients who take Vitamin E or Pioglitazone.
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 |
|---|---|---|
| 275mg Oligo Fucoidan + 275mg HS FucoxanthinFucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules. | Other | Fucoidan use |
| placebo pillstaking placebo pills as if patients are under treatment. | Other | placebo pills |
Primary outcome
Change in ALT Index
Time frame: 6 months
Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.
Change in AST Index
Time frame: 6 months
Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation
Change in HbA1c
Time frame: 6 months
Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ming-Shung Wu, Doctor study director
Wanfang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 275mg Oligo Fucoidan + 275mg HS Fucoxanthin in people with Non-alcoholic Fatty Liver Disease, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ALT Index (time frame: 6 months). The study lists 3 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 NCT02875392, 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 13 Apr 2021.