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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014736
Receipt No. R000017131
Scientific Title Clinical trial of effectiveness of Citrus unshiu juice enriched with beta-cryptoxanthin, vitamin E and zinc for nonalcoholic fatty liver disease
Date of disclosure of the study information 2014/08/01
Last modified on 2016/06/15

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Basic information
Public title Clinical trial of effectiveness of Citrus unshiu juice enriched with beta-cryptoxanthin, vitamin E and zinc for nonalcoholic fatty liver disease
Acronym Clinical trial of effectiveness of Citrus unshiu juice enriched with beta-cryptoxanthin, vitamin E and zinc for NAFLD
Scientific Title Clinical trial of effectiveness of Citrus unshiu juice enriched with beta-cryptoxanthin, vitamin E and zinc for nonalcoholic fatty liver disease
Scientific Title:Acronym Clinical trial of effectiveness of Citrus unshiu juice enriched with beta-cryptoxanthin, vitamin E and zinc for NAFLD
Region
Japan

Condition
Condition nonalcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We previously reported that in patients with nonalcoholic steatohepatitis (NASH) there were low intakes of b-cryptoxanthin (b-crypt), vitamin E and zinc. We also reported that b-crypt-enriched Citrus unshiu juice would be effective for improving biochemical parameters in NASH patients. In this study, we conduct a clinical trial to access whether Citrus unshiu juice enriched with b-crypt, vitamin E and zinc is more effective than that enriched with only b-crypt for nonalcoholic fatty liver disease (NAFLD) patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of serum biochemical parameters (liver enzyme) about NAFLD
Key secondary outcomes Improvement of chronic inflammation and anti-oxidant

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 enriched with beta-cryptoxanthin, vitamin E and zinc
Interventions/Control_2 enriched with beta-cryptoxanthin
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All subjects provide written informed consent
All subjects are histologically diagnosed as NAFLD
All subjects are over 20 years old, any sexuality and body mass index
In subjects with diabetes mellitus concentration levels of FPG are under 140mg/dl and levels of HbA1c are under 7.0%
Key exclusion criteria Patients with any other liver injury
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Bunzo Matsuura
Organization Ehime University Graduate School of Medicine
Division name Lifestyle-related Medicine and Endocrinology
Zip code
Address Shitsukawa 454, Toon, Ehime
TEL 089-960-5308
Email bmatsu@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Bunzo Matsuura
Organization Ehime University Graduate School of Medicine
Division name Lifestyle-related Medicine and Endocrinology
Zip code
Address Shitsukawa 454, Toon, Ehime
TEL 089-960-5308
Homepage URL
Email bmatsu@m.ehime-u.ac.jp

Sponsor
Institute Ehime University, Internal Medicine
Institute
Department

Funding Source
Organization Ehime University, Lifestyle-related Medicine and Endocrinology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Both trial beverages had the same effect that serum GGT levels were decreased in NAFLD patients accompanied by decreases of serum oxLDL and IL6 levels and increases of serum SOD and IL10 levels. These findings suggest that b-cryptoxanthin treatment is effective in promoting anti-oxidant and anti-inflammation activities in NAFLD patients.
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 Completed
Date of protocol fixation
2014 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 01 Day
Last modified on
2016 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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