UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effect of intake of ingredients derived from animal on cognitive functions.
Title of the study (Brief title)	A study for the effect of intake of ingredients derived from animal on cognitive functions.
Region	Japan

Condition
Condition	None
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 and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

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 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

Research contact person
Name of lead principal investigator	Sumio Kondo
Organization	Fukushima Healthcare Center
Division name	Internal Medicine
Address	2-12-16 Tamakawa, Fukusima-ku, Osaka-shi, Osaka
TEL	06-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Address	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)

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	2016 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 27 Day
Last modified on	2016 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025914