UMIN-CTR Clinical Trial

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

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

Kirin company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

06

Month

05

Day

Last modified on

2017

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=R000031672