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

Email

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


Email

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


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

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