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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020006
Receipt No. R000023096
Scientific Title A study for the effect of intake of bitter component derived from hops on cognitive functions.
Date of disclosure of the study information 2015/11/30
Last modified on 2016/12/05

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Basic information
Public title A study for the effect of intake of bitter component derived from hops on cognitive functions.
Acronym A study for the effect of intake of bitter component derived from hops on cognitive functions.
Scientific Title A study for the effect of intake of bitter component derived from hops on cognitive functions.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuki Mihara
Organization HUMA R&D CORP
Division name President
Zip code
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
1st name
Middle name
Last name Toshiki Kataoka
Organization HUMA R&D CORP
Division name Business Promotion Division
Zip code
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.

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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 30 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 11 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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