Trial Outcomes & Findings for Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (NCT NCT02875392)

NCT ID: NCT02875392

Last Updated: 2021-04-13

Results Overview

Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-04-13

Participant Flow

Participant milestones

Measure	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.	Placebo Pills placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment.
Overall Study STARTED	28	29
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Measure	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.	Placebo Pills placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment.
Overall Study The subjects did not inform their Hepatobiliary disorders; hence, their data did not analyze	7	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fucoidan Use n=28 Participants 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.	Placebo Pills n=29 Participants placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment.	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=28 Participants	0 Participants n=29 Participants	0 Participants n=57 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=28 Participants	18 Participants n=29 Participants	42 Participants n=57 Participants
Age, Categorical >=65 years	4 Participants n=28 Participants	11 Participants n=29 Participants	15 Participants n=57 Participants
Sex: Female, Male Female	11 Participants n=28 Participants	21 Participants n=29 Participants	32 Participants n=57 Participants
Sex: Female, Male Male	17 Participants n=28 Participants	8 Participants n=29 Participants	25 Participants n=57 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 months

Measure the first month and the sixth-month change in the index which is ALT related to Liver inflammation.

Outcome measures

Measure	Fucoidan Use n=21 Participants 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.	Placebo Pills n=21 Participants placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment.
Change in ALT Index First Month	42.238 U/L Standard Deviation 17.196	33.524 U/L Standard Deviation 21.736
Change in ALT Index Sixth Month	36.667 U/L Standard Deviation 16.01	36.238 U/L Standard Deviation 22.221

PRIMARY outcome

Timeframe: 6 months

Measure the first month and the sixth-month change in the index which is AST relate to Liver inflammation

Outcome measures

Measure	Fucoidan Use n=21 Participants 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.	Placebo Pills n=21 Participants placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment.
Change in AST Index First Month	28.095 U/L Standard Deviation 7.049	27.905 U/L Standard Deviation 15.776
Change in AST Index Sixth Month	25.286 U/L Standard Deviation 7.349	28.048 U/L Standard Deviation 14.165

PRIMARY outcome

Timeframe: 6 months

Measure the first month and the sixth-month change in the index which is HbA1c relate to Liver inflammation

Outcome measures

Measure	Fucoidan Use n=21 Participants 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.	Placebo Pills n=21 Participants placebo capsule 6 per day (before breakfast and supper) placebo pills: taking placebo pills as if patients are under treatment.
Change in HbA1c First Month	5.871 percentage of glycated hemoglobin Standard Deviation 0.443	6.057 percentage of glycated hemoglobin Standard Deviation 0.451
Change in HbA1c Sixth Month	5.79 percentage of glycated hemoglobin Standard Deviation 0.525	6.152 percentage of glycated hemoglobin Standard Deviation 0.608

Adverse Events

Fucoidan Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Pills

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ming-Shun Wu

Taipei Municipal Wanfang Hospital

Phone: +886229307930

Email: vw1017@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place