UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018361
Receipt number R000021258
Scientific Title Efficacy and safety of high dose catechin-contained green tea in patients with NAFLD
Date of disclosure of the study information 2015/07/21
Last modified on 2015/07/21 08:45:44

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Basic information

Public title

Efficacy and safety of high dose catechin-contained green tea in patients with NAFLD

Acronym

Green tea in NAFLD treatment

Scientific Title

Efficacy and safety of high dose catechin-contained green tea in patients with NAFLD

Scientific Title:Acronym

Green tea in NAFLD treatment

Region

Japan


Condition

Condition

Nonalcoholic fatty liver disease (NAFLD)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

A blinded evaluation of efficacy and safety of high dose catechin-contained green tea in patients with NAFLD

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in serum ALT levels

Key secondary outcomes

-Hepatic histological improvement in nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
-NASH diagnosis:
Change from definite or indeterminate NASH to not-NASH
-Change in hepatic fat intensity and abdominal fat area determined by CT
-Change in fibrosis:
Serum collagen4-7S, P-3-P, hyaluronic acid
Intensity of fibrosis and steatosis determined by fibroscan
-Change in fasting glucose, insulin, HbA1c, glycated albumin, hsCRP
-Change in fasting markers of insulin resistance (HOMA-IR)
-Change in waist circumference, body weight, body mass index, body fat ratio, body fat mass, abdominal visceral fat area, and abdominal subcutaneous fat area
-Changes in lipid metabolism (T-chol, LDL-c, TG, FFA, RLP-Cho, oxidized LDL, sdLDL and fatty acid fraction)
circumference, basal metabolism, and blood pressure
-Change in AST and gamma-glutamyl transpeptidase (GGT)
-Change in cytokine and oxidative stress marker (EC-SOD, 8-isoprostanes, 8-OHdG, IL-1beta, G-CCF, TNFR, IL-6, IL-10)
-Change in gene sets in liver and plasma determined by DNA chip
-Changes in metabolites in plasma and liver by metabolome analysis
-Adverse effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Catechin beverage (containing 540 mg of catechins/350mL) 1 bottle per day for 48 weeks.

Interventions/Control_2

Control beverage (containing 0 mg of catechins/350mL) 1 bottle per day for 48 weeks.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who are
1) 18 years of age or older as of the initial screening interview and provision of consent
2) are histologically diagnosed as NAFLD by liver biopsy within 5 years at time of consent
3) have ALT 30 and higher
4) have alcohol intake 30 gram and less for male, and 20 gram and less for female

Key exclusion criteria

Subjects who
1) are infected with HBV or HCV
2) have alcohol intake more than 30 for male, and more than 20 gram for female
3) have malignant tumor including hepatocellular carcinoma

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuguhito Ota

Organization

Kanazawa University

Division name

Department of Medicine

Zip code


Address

13-1 Takara-machi, Kanazawa

TEL

076-265-2234

Email

tota@staff.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuguhito Ota

Organization

Kanazawa University

Division name

Department of Medicine

Zip code


Address

13-1 Takara-machi, Kanazawa

TEL

076-265-2234

Homepage URL


Email

tota@staff.kanazawa-u.ac.jp


Sponsor or person

Institute

Kanazawa University Department of Disease Control and Homeostasis

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2014 Year 08 Month 27 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 21 Day

Last modified on

2015 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021258


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name