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

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 and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

<Efficacy>
Test for memory functions and test for attention functions at 4, 8 weeks after intervention.

Key secondary outcomes

<Efficacy>
Test for memory functions
Test for attention functions
Test for mental status.
<Safety>
Objective response, subjective symptom, body weight, blood pressure, pulse, hematology test, biochemical test, urinalysis

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingredients derived from animal, once a day, 8 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

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 with self-awareness of forgetfulness
3)Subjects with inferior scores of cognitive function tests.

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 the HDS-R score 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 study.
9)Heavy drinkers.
10)Smokers or subjects who started smoking cessation within 12 months.
11)Subjects who have taken the same cognitive function tests.
12) Subjects who are being treated for cognitive functions,or who are prescribed drugs associated with cognitive functions.
13)Subjects who regularly take drugs or health foods which may affect on brain functions more than once a week.
14)Subjects who regularly take foods similar to test foods.
15)Subjects who regularly take energy drinks more than once a week.
16)Subjects who have done blood transfusion or blood donation within 3 months.
17)Subjects who have participated other clinical studies within 1 month,or who are planning to participate 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 for lifestyle questionnaire.
23)Subjects who and 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

30

Name of lead principal investigator

1st name
Middle name
Last name	Sumio Kondo

Organization

Fukushima Healthcare Center

Division name

Internal Medicine

Zip code

Address

2-12-16 Tamakawa, Fukusima-ku, Osaka-shi, Osaka

TEL

06-6882-1130

Email

s.kondo@drc-web.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

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

2016

Year

05

Month

31

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

Completed

Date of protocol fixation

2016

Year

05

Month

12

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

27

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=R000025914