UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014736 |
|---|---|
| Receipt number | 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 06:37:04 |
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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
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
bmatsu@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University, Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017131
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