Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: Taipei Medical University WanFang Hospital

TMU-JIRB Form059/20160306 
Protocol version: V1.2 
Protocol date: 20160704 
 
Taipei Medical University 
TMU-Joint Institutional Review Board 
 
Protocol: Fucoidan Improves the Metabolic 
Profiles of Patients with Non-alcoholic 
Fatty Liver Disease (NAFLD) 
 
 
Protocol Version/date: V1.2/ 20160704 
 
Identifiers: NCT02875392 
Unique Protocol: N201605071 
 
 
 
 

1. Study Protocol 
In this study, a double-blind randomized experimental design was used to allow 
subjects to take six months of health supplements (experimental group) and six 
months of placebo (control group) to see their effects on fatty liver, liver fibrosis and 
metabolic indicators. 
First ask the patient to agree to participate in the trial and fully understand the 
content of the project. After the eligible subjects are evaluated and confirmed to be 
able to participate in the trial, they will take health care products daily according to 
the research setting (3 tablets before breakfast, 3 tablets before dinner, total 6 tablets ), 
at the first time of the test, 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 24 weeks 
respectively to check blood and biochemical values, including creatinine (Cr), liver 
function index (AST, ALT), pre-meal blood sugar (AC) , And use Fibroscan to detect 
fatty liver and liver fibrosis. At the first time of the test, 4 weeks, 12 weeks, and 24 
weeks, return to check blood routine / white blood cell classification examination 
(CBC/DC), uric acid (UA), cholesterol blood fat (HDL, LDL), triglyceride (TG), lipid 
Adiponectin/Leptin (Adiponectin/Leptin), C-reactive protein (CRP), insulin (Insulin); 
In addition, at the first, 12 weeks, and 24 weeks of the test, the metabolic indicators 
related to glycosylated hemoglobin (HbA1c) were tested. 
This study will extract the follow-up data of subjects' return visits for analysis 
and research. The follow-up methods are phone reminders two weeks before the start 
of the trial, and reminders during monthly visits, asking about taking status, etc., to 
increase the subjects’ compliance. 
2. Study procedures 
 

3. Statistical Analysis Plan 
This study is expected to include a total of 60 people with non-alcoholic fatty 
liver disease, divided into two groups, 30 people in each group, double-blind 
randomized test. The primary end point (primary end point) is to see the severity of 
changes in the patient’s steatohepatitis and fibrosis. The secondary end point is the 
degree of change in the patient’s weight and lipid profile. Continuous variables are 
presented in normal probability plots and Shapiro-Wilk test evaluation. The 
relationship between variables Connectivity is analyzed by Pearson’s correlation, and 
the Intra-intervention comparison is performed by Paired t test. Unify The calculation 
software is based on R software version 2.11.1.