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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027644
Receipt No. R000031672
Scientific Title A study for the effect of intake of ingredients derived from animal on cognitive functions
Date of disclosure of the study information 2018/12/30
Last modified on 2017/12/05

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Basic information
Public title A study for the effect of intake of ingredients derived from animal on cognitive functions
Acronym A study for the effect of intake of ingredients derived from animal on cognitive functions
Scientific Title A study for the effect of intake of ingredients derived from animal on cognitive functions
Scientific Title:Acronym A study for the effect of intake of ingredients derived from animal 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 animal 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 animal, 6 tablets a day, 12 weeks
Interventions/Control_2 Intake of placebo 6 tablets 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 1)Men and women aged from 45 to 64
2)Subjects whose primary language is Japanese
3)Subjects with self-awareness of forgetfulness, especially who often forget the name of people, or objects
4)Subjects who often carelessly make mistakes in daily life
5)Subjects with inferior scores of primary outcome
Key exclusion criteria 1)Subjects who have difficulties in recognition of colors
2)Subjects whose visual or hearing acuity is too low to perform tests, or who have been diagnosed as amblyopia, blindness, or deafness
3)Subjects whose score of the HDS-R is less than 20
4)Subjects who have anamnesis of cranial nerve disease
5)Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
6)Subjects who are being treated with hormone, or who have been diagnosed as menopausal symptoms
7)Subjects who sometimes have irregular lifestyles during the study
8)Heavy drinkers
9)Smokers or subjects who started smoking cessation within 12 months
10)Subjects who have taken the similar cognitive function tests within 12 months
11)Subjects who are being treated for cognitive functions, or who are prescribed drugs associated with cognitive functions
12)Subjects who regularly take drugs or health foods which may affect cognitive functions more than once a week
13)Subjects who regularly take foods similar to test foods more than once a week
14)Subjects who regularly take energy drinks more than once a week
15)Subjects who have done blood transfusion or blood donation within 3 months
16)Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study
17)Subjects who have diseases requiring regular administration, or who have severe diseases
18)Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value
19)Subjects who may have physical deconditioning due to test foods
20)Subjects who are, or are planning to be pregnant or breastfeeding during study
21)Subjects who are judged as unsuitable due to lifestyle questionnaire
22)Subjects who and whose family work in a company developing functional foods
23)Subjects who are judged as unsuitable by doctor for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniaki Obara
Organization Kirin company, Limited
Division name Research and Development division, Research Laboratories for Health Science & Food Technologies
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 Takashi Nakagawa
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 t.nakagawa@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
2018 Year 12 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 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 06 Month 05 Day
Last modified on
2017 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=R000031672

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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