UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017916 |
|---|---|
| Receipt number | R000020768 |
| Scientific Title | Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Mulberry Leaf Tea on the improvement of Liver Function |
| Date of disclosure of the study information | 2015/06/16 |
| Last modified on | 2016/07/15 13:29:23 |
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Basic information
Public title
Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Mulberry Leaf Tea on the improvement of Liver Function
Acronym
The Effect of Daily Ingestion of the Mulberry Leaf Tea on the improvement of Liver Function
Scientific Title
Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Mulberry Leaf Tea on the improvement of Liver Function
Scientific Title:Acronym
The Effect of Daily Ingestion of the Mulberry Leaf Tea on the improvement of Liver Function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the clinical usefulness of liver function improvement by investigating effects from daily ingestion of Mulberry Leaf Tea for 8 weeks.
To evaluate the overall health promotion by secondarily examining effects of body weight reduction, lipid metabolism, blood glucose and gene expression profiles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
ALT
Key secondary outcomes
AST, gamma GTP,ALP,LDH,T-Cho, HDL-Cho, LDL-Cho, TG, NEFA,
TP, Alb, T-Bil, A/G ratio, fasting plasma glucose, HbA1c, Insulin, blood RNA, fecal intestinal bacterial flora, body weight, body fat rate, BMI, VAS questionnaire, NAFLD fibrosis score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the Mulberry Leaf Tea daily for 8 weeks
Interventions/Control_2
Ingestion of the placebo tea daily for 8 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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male subjects whose ALT is more than 26U/I, female subjects whose ALT is more than 18U/l.
2. Subjects whose BMI is between 23 and 30.
3. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects who are under treatment and medication for hyperlipidemia, and diabetes.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities
3. Subjects with liver disease except for NAFLD.
4. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure or abnormal hematological data
6. Subjects with serious anemia
7. Pre- or post-menopausal subjects having complaints of obvious physical changes
8. Subjects who are at risk of having allergic reactions to drugs or foods (especially Mulberry leaf, brown rice and/or spinach )
9. Subjects regularly take medicine , functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, and/or dietary fiber, etc.) which would affect the blood lipids.
10. Subjects regularly take medicine functional foods and/or supplements based on dietary fiber from resistant dextrin, and/or polyphenols, etc. which would affect the blood glucose.
11. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
12. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
13. Subjects who are pregnant or expected to be pregnant, or lactating during the study
14. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial
15. Any other medical reasons judged by the principal investigator
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Center of Health Information Science
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Academy of Science and Technology Project for development of food functionality assessment methods
Organization
Division
Category of Funding Organization
Non profit foundation
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
北海道情報大学 保健センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 16 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 22 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020768
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