Non-alcoholic Fatty Liver Disease
Conditions
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.
Interventions
OTHER275mg 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.
OTHERplacebo pills
taking placebo pills as if patients are under treatment.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).
Exclusion criteria
1. Patients were allergic to seafood. 2. Patients who take Vitamin E or Pioglitazone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALT Index | 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 | 6 months | Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation |
| Change in HbA1c | 6 months | Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Placebo Pills placebo capsule 6 per day (before breakfast and supper)
placebo pills: taking placebo pills as if patients are under treatment. | 29 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | The subjects did not inform their Hepatobiliary disorders; hence, their data did not analyze | 7 | 8 |
Baseline characteristics
| Characteristic | Fucoidan Use | Placebo Pills | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 11 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 18 Participants | 42 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 32 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 0 / 28 | 0 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
Primary
Change in ALT Index
Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fucoidan Use | Change in ALT Index | First Month | 42.238 U/L | Standard Deviation 17.196 |
| Fucoidan Use | Change in ALT Index | Sixth Month | 36.667 U/L | Standard Deviation 16.01 |
| Placebo Pills | Change in ALT Index | First Month | 33.524 U/L | Standard Deviation 21.736 |
| Placebo Pills | Change in ALT Index | Sixth Month | 36.238 U/L | Standard Deviation 22.221 |
Primary
Change in AST Index
Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fucoidan Use | Change in AST Index | First Month | 28.095 U/L | Standard Deviation 7.049 |
| Fucoidan Use | Change in AST Index | Sixth Month | 25.286 U/L | Standard Deviation 7.349 |
| Placebo Pills | Change in AST Index | First Month | 27.905 U/L | Standard Deviation 15.776 |
| Placebo Pills | Change in AST Index | Sixth Month | 28.048 U/L | Standard Deviation 14.165 |
Primary
Change in HbA1c
Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fucoidan Use | Change in HbA1c | First Month | 5.871 percentage of glycated hemoglobin | Standard Deviation 0.443 |
| Fucoidan Use | Change in HbA1c | Sixth Month | 5.79 percentage of glycated hemoglobin | Standard Deviation 0.525 |
| Placebo Pills | Change in HbA1c | First Month | 6.057 percentage of glycated hemoglobin | Standard Deviation 0.451 |
| Placebo Pills | Change in HbA1c | Sixth Month | 6.152 percentage of glycated hemoglobin | Standard Deviation 0.608 |