UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of hops intake on brain structure and function
Title of the study (Brief title)	The effect of hops intake on brain structure and function
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Compare the effects of hops with non-intake group
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in brain structure and function
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Single ingestion of hops for 4 weeks
Interventions/Control_2	no treatment
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	45 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Subjects who have given written informed consent 2) Healthy subjects aged 45 to 65 years old
Key exclusion criteria	1) Person who received treatment in the past such as pacemaker, cochlear implant, cerebral artery clip 2) Claustrophobia, 3) Persons whose metals such as artificial joints are embedded in the body, Those who put tattoos, tattoos, etc.
Target sample size	30

Research contact person
Name of lead principal investigator	Susumu Kajiwara
Organization	Tokyo Institute of Technology
Division name	School of Life Science and Technology
Address	4259, Nagatsuta-cho, Midori-ku, Yokohama, Kanagawa
TEL	045-924-5716
Email	ethics@cnspi..titech.ac.jp

Public contact
Name of contact person	Yasuharu Koike
Organization	Tokyo Institute of Technology
Division name	Institute of Innovative Research
Address	4259, Nagatsuta-cho, Midori-ku, Yokohama, Kanagawa
TEL	045-924-5054
Homepage URL
Email	ethics@cns.pi.titech.ac.jp

Sponsor
Institute	Tokyo Institute of Technology
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 06 Month 28 Day
Last follow-up date	2018 Year 09 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 28 Day
Last modified on	2018 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037828