UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Mulberry Leaf Tea on the improvement of Liver Function
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Center of Health Information Science
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020768