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
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
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
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
