Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

NCT02875392 | Completed Results

• 1 other identifier: N201605071
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Fucoidan use

EXPERIMENTAL

FucoHiQ(275mg Oligo Fucoidan + 275mg HS Fucoxanthin) 550mg/capsule 6 per day(before breakfast and supper)

Other: 275mg Oligo Fucoidan + 275mg HS Fucoxanthin

placebo pills

PLACEBO COMPARATOR

placebo capsule 6 per day (before breakfast and supper)

Other: placebo pills

Interventions

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.

Fucoidan use

placebo pills OTHER

taking placebo pills as if patients are under treatment.

placebo pills

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).

You may not qualify if:

• Patients were allergic to seafood.
• Patients who take Vitamin E or Pioglitazone.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFangH

Taipei, 116, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33993853 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Ming-Shun Wu
• Organization: Taipei Municipal Wanfang Hospital

vw1017@gmail.com

+886229307930

Study Officials

• Ming-Shung Wu, Doctor

  Wanfang Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 23, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 13, 2021
• Results First Posted: March 17, 2021

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)