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

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 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


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

Value
https://center6.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