UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effect of intake of bitter component derived from hops on cognitive functions.
Title of the study (Brief title)	A study for the effect of intake of bitter component derived from hops on cognitive functions.
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the effects of intake of the bitter component derived from hops on cognitive functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	<Efficacy> Measurements of brain images using fMRI after intervention for 4 weeks.
Key secondary outcomes	<Efficacy> Questionnaires.

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
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Bitter components derived from hops, once a day, 4 weeks
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	50 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects aged from 50 to 70 years old 2) Subjects who are healthy, right-handed, and have Japanese Nationalities. 3) Subjects who do not intake alcoholic beverages and foods and bevarages containning hops, or intake less than one day a week. 4) Subjects who can refrain from intake of foods and bevarages containning hops during the current study. 5) Subjects who do not satisfy key exclusion criteria.
Key exclusion criteria	1) Subjects who have a smoking habit. 2) Subjects with serious hepatic, renal, and cardiovascular dysfunction (including anamnesis). 3) Subjects who are constantly being treated by drugs. 4) Subjects who are being treated by kinesiology, or dietary cure under control by doctors. 5) Subjects with medicine allergy, or food allergy. 6) Subjects with drug dependence, or drug abuse (including anamnesis). 7) Subjects who work at night, or work irregularly. 8) Subjects who are pregnant or lactating, or planned to become pregnant. 9) Subjects who participate in other clinical studies. 10) Subjects with artificial cardiac pacemakers. 11) Subjects with vascular clips. 12) Subjects with Electrical stimulator for nerves. 13) Subjects with embedded pumps. 14) Subjects who have piece of metals in their bodies by some reasons (including accidents or injured) 15) Subjects with tattoos 16) Subjects who have piece of metals or screws in their bodies by some treatment, such as broken bones. 17) Subjects who dye their hair by coloring containing metals. 18) Subjects with glycerin patches. 19) Subjects with artifacts in their ears. 20) Subjects with injuries by metals. 21) Subjects who have experiences of surgery. 22) Subjects with intrauterine devices. 23) Subjects with dental instruments containing metals. 24) Subjects with artificial eyes. 25) Subjects who have experiences of labyrinth disease such as Meniere's disease. 26) Subjects with artificial cardiac valves. 27) Subjects with claustrophobia or nyctophobia. 28) Subjects with dyskinesia. 29) Subjects with severe visual disorder or hearing impairments. 30) Subjects who have experiences of heart seizures. 31) Subjects who have experiences of epileptic seizures. 32) Subjects with migraines. 33) Subjects who have had bad feelings seeing sparkling lights. 34)Subjects who have occupational history of polishing metals.
Target sample size	30

Research contact person
Name of lead principal investigator	Yuki Mihara
Organization	HUMA R&D CORP
Division name	President
Address	1-27-12 Hamamatsu-cho, Minato-ku, Tokyo, Japan
TEL	03-3431-1260
Email	mihara@huma-c.co.jp

Public contact
Name of contact person	Toshiki Kataoka
Organization	HUMA R&D CORP
Division name	Business Promotion Division
Address	1-27-12 Hamamatsu-cho, Minato-ku, Tokyo, Japan
TEL	03-3431-1260
Homepage URL
Email	kataoka@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Kirin Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	The University of Tokyo
Name of secondary funｄer(s)	Impulsing Paradigm Change through disruptive Technologies.

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	2015 Year 11 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 04 Day
Anticipated trial start date	2015 Year 11 Month 10 Day
Last follow-up date
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	2015 Year 11 Month 30 Day
Last modified on	2016 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023096