UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation study of food containing plant extract
Acronym	Safety evaluation study of food containing plant extract
Scientific Title	Safety evaluation study of food containing plant extract
Scientific Title:Acronym	Safety evaluation study of food containing plant extract
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to confirm the safety of taking the test food for 12 consecutive weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Side effects and adverse events (Physical measurements, blood tests, urinalysis, vitals, doctor consultation)
Key secondary outcomes	RBMT(The Rivermead Behavioral Memory Test)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of the test food for 12 weeks (3 tablets / day)
Interventions/Control_2
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Japanese male and female over 40 years old at the time of the informed consent. 2)Subjects who do not take medication or health food continuously. 3)Subjects whose Moca-J score is ranged from 18 to 28 before intake of the test food. 4) Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to make a self-judgment, voluntarity participate in the study after understanding the content enough and agree to participate in the study by signing the written informed consent. 5) Subjects who are able to visit the hospital regularly and are able to take the test food at home.
Key exclusion criteria	1) Subjects who have an allergy to the test food. 2) Subjecte whose GDS score is more than 10 before intake of the test food. 3)Subjects who has participated in other clinical studies (clinical trials) within 3 months before the start of the test or who is planning to participate in other clinical studies (clinical trials) during the study period. 4) Subjects who is current disease or a history of diabetes, liver disease (hepatitis), renal disease, serious diseases such as heart disease, thyroid disease, adrenal disease, or other metabolic diseases. 5)Subjects who are judged as unsuitable for the study by principal investigator or sub-investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name tazuo Middle name Last name okuno
Organization	Kanazawa Medical University
Division name	Department of Geriatrics
Zip code	920-0293
Address	1-1 University, Uchinada town, Kahoku county, Ishikawa
TEL	076-286-2211
Email	ma6-0219@kanazawa-med.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Hama
Organization	Kanazawa Medical University Hospital
Division name	Dementia Center
Zip code	920-0293
Address	1-1 University, Uchinada town, Kahoku county, Ishikawa
TEL	076-286-3511
Homepage URL
Email	hama-d@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethical committees of the Kanazawa Medical University
Address	1-1 University, Uchinada town, Kahoku county, Ishikawa
Tel	076-218-8346
Email	tiken@kanazawa-med.ac.jp

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	2020 Year 07 Month 01 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	2020 Year 01 Month 30 Day
Date of IRB	2020 Year 02 Month 12 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 01 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045075