Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
275mg Oligo Fucoidan + 275mg HS Fucoxanthin
placebo pills
Sponsored by
About this trial
This is an interventional other trial for Non-alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).
Exclusion Criteria:
- Patients were allergic to seafood.
- Patients who take Vitamin E or Pioglitazone.
Sites / Locations
- WanFangH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fucoidan use
placebo pills
Arm Description
FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)
placebo capsule 6 per day (before breakfast and supper)
Outcomes
Primary Outcome Measures
Change in ALT Index
Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.
Change in AST Index
Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation
Change in HbA1c
Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation
Secondary Outcome Measures
Full Information
NCT ID
NCT02875392
First Posted
August 5, 2016
Last Updated
March 18, 2021
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02875392
Brief Title
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Official Title
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fucoidan use
Arm Type
Experimental
Arm Description
FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)
Arm Title
placebo pills
Arm Type
Placebo Comparator
Arm Description
placebo capsule 6 per day (before breakfast and supper)
Intervention Type
Other
Intervention Name(s)
275mg Oligo Fucoidan + 275mg HS Fucoxanthin
Intervention 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 subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
Intervention Type
Other
Intervention Name(s)
placebo pills
Intervention Description
taking placebo pills as if patients are under treatment.
Primary Outcome Measure Information:
Title
Change in ALT Index
Description
Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.
Time Frame
6 months
Title
Change in AST Index
Description
Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation
Time Frame
6 months
Title
Change in HbA1c
Description
Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).
Exclusion Criteria:
Patients were allergic to seafood.
Patients who take Vitamin E or Pioglitazone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shung Wu, Doctor
Organizational Affiliation
Wanfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
WanFangH
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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
Learn more about this trial
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
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