UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020006 |
|---|---|
| Receipt number | 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 10:24:05 |
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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
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
kataoka@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023096
