UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029572 |
|---|---|
| Receipt number | 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 | 2019/10/18 23:06:17 |
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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 | Kuniaki |
| Middle name | |
| Last name | Obara |
Organization
Kirin company, Limited
Division name
Research Laboratories for Health Science and Food Technologies, Research and Development Division
Zip code
236-0004
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL
080-1930-9932
k-obara@kirin.co.jp
Public contact
Name of contact person
| 1st name | Isobe |
| Middle name | |
| Last name | Kotoha |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
2360004
Address
Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
k.isobe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno clinic
Address
2-18-6, Higashi-Ueno, Taito-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.jp
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 28 | Day |
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
| 2019 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033783
