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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029572
Receipt No. R000033783
Scientific Title A study for the effect of intake of ingredients derived from plant on cognitive functions
Date of disclosure of the study information 2019/04/14
Last modified on 2017/10/16

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Basic information
Public title A study for the effect of intake of ingredients derived from plant on cognitive functions
Acronym A study for the effect of intake of ingredients derived from plant on cognitive functions
Scientific Title A study for the effect of intake of ingredients derived from plant on cognitive functions
Scientific Title:Acronym A study for the effect of intake of ingredients derived from plant on cognitive functions
Region
Japan

Condition
Condition None (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of intake of ingredients derived from plant on cognitive functions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tests for memory functions
Key secondary outcomes Tests for memory functions
Tests for attention functions
Tests for executive functions
Tests for mental status
Questionnaires

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of food containing ingredients derived from plant, 3 capsules a day, 12 weeks
Interventions/Control_2 Intake of placebo 3 capsules a day, 12 weeks
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
64 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who fall under all of the following 1) to 6)
1)Men and women aged from 45 to 64
2)Subjects whose primary language is Japanese
3)Subjects with self-awareness of decline of the brain or forgetfulness
4)Subjects who often forget the name of people or objects
5)Subjects who often carelessly make mistakes in daily life
6)Subjects with inferior scores of primary outcome in preliminary test
Key exclusion criteria 1)Subjects who have difficulties in recognition of colors
2)Subjects whose visual acuity is too low to perform tests, or who have been diagnosed as amblyopia or blindness
3)Subjects whose hearing acuity is too low to perform test, or who have been diagnosed as deafness
4)Subjects whose score of the HDS-R is less than 20
5)Subjects who have anamnesis of cranial nerve disease
6)Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
7)Subjects who are being treated with hormone, or who have been diagnosed as menopausal symptoms
8)Subjects who sometimes have irregular lifestyles during the study
9)Heavy drinkers
10)Smokers or subjects who started smoking cessation within 12 months
11)Subjects who have taken the similar cognitive function tests within 12 months
12)Subjects who are being treated for cognitive functions, or who are prescribed drugs associated with cognitive functions
13)Subjects who suffer from sleep related diseases
14)Subjects who regularly take drugs or health foods which may affect study results more than once a week
15)Subjects who have done blood transfusion or blood donation within 3 months
16)Subjects who regularly take foods similar to test foods more than once a week
17)Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study
18)Subjects who have diseases requiring regular administration, or who have severe diseases
19)Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value
20)Subjects who may have allergy to test foods
21)Subjects who are, or are planning to be pregnant or breastfeeding during study
22)Subjects who are judged as unsuitable due to lifestyle questionnaire
23)Subjects who or whose family work in a company developing or manufacturing functional foods
24)Subjects who are judged as unsuitable by doctor for other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniaki Obara
Organization Kirin company, Limited
Division name Research Laboratories for Health Science and Food Technologies, Research and Development Division
Zip code
Address 1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL 080-1930-9932
Email k-obara@kirin.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isobe Kotoha
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email k.isobe@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
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
Name of secondary funder(s)

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
2019 Year 04 Month 14 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 18 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
2017 Year 10 Month 16 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033783

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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