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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucoidan use | Experimental | FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper) |
|
| placebo pills | Placebo Comparator | placebo capsule 6 per day (before breakfast and supper) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 275mg Oligo Fucoidan + 275mg HS Fucoxanthin | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ALT Index | Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation. | 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 | 6 months |
| Change in HbA1c | Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Shung Wu, Doctor | Wanfang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WanFangH | Taipei | 116 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33993853 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fucoidan Use | FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper) 275mg Oligo Fucoidan + 275mg HS Fucoxanthin: 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. |
| FG001 | Placebo Pills | placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fucoidan Use | FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper) 275mg Oligo Fucoidan + 275mg HS Fucoxanthin: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in ALT Index | Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation. | Posted | Mean | Standard Deviation | U/L | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fucoidan Use | FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper) 275mg Oligo Fucoidan + 275mg HS Fucoxanthin: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ming-Shun Wu | Taipei Municipal Wanfang Hospital | +886229307930 | vw1017@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2016 | Jan 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
| placebo pills | Other | taking placebo pills as if patients are under treatment. |
|
| BG001 | Placebo Pills | placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
placebo capsule 6 per day (before breakfast and supper)
placebo pills: taking placebo pills as if patients are under treatment.
|
|
| Primary | Change in AST Index | Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation | Posted | Mean | Standard Deviation | U/L | 6 months |
|
|
|
| Primary | Change in HbA1c | Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 6 months |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Placebo Pills | placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment. | 0 | 29 | 0 | 29 | 0 | 29 |
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