UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on the action of botanical extracts on brain functions
Title of the study (Brief title)	Examination on the action of botanical extracts on brain functions
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine an influence of a test food product on brain functions by selecting healthy males and females of Japanese nationality aged 50 and over, below 70 as subjects and assigning them to take the test food product for 12 weeks on a continuous basis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement effects of Cognitrax on brain functions
Key secondary outcomes	Blood concentration of BDNF, blood concentration of inflammatory cytokines(TNF-,IL-6,IL-1), BAP levels and d-ROMs in blood, urinary 8-0HdG, and isoprostane in urine

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	Prevention
Type of intervention	Food
Interventions/Control_1	4-week intake of the test food
Interventions/Control_2	4-week intake of the placebo food
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	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Age: 50 and over, below 70 2)Sex: Males and females with Japanese nationality 3)Persons who are aware of a decline in cognitive functions
Key exclusion criteria	1)Currently in treatment with medication or currently seeing a doctor for treatment 2)Previous history of hepatic disorder, severe kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disorder, or a complication of these. 3)Previous history of drug allergy or food allergy 4)Current intake of a health food product or supplements with a possible influence on the cognitive functions 5)Current administration of medication with a possible influence on the cognitive functions 6)Extreme faddiness 7)Extremely irregular lifestyle habits such as eating and sleeping habits 8)Suspected insomnia 9)Presence or previous history of mental disorder (depression, etc.) 10)Presence or previous history of alcoholism 11)Current participation in any other clinical study or participation in other clinical study in the past three months 12)Night shifts or irregular work schedule 13)Determined by the investigator to be unsuitable for enrollment in this study
Target sample size	60

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd.
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	2017 Year 11 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 13 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2018 Year 02 Month 23 Day
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	2017 Year 11 Month 22 Day
Last modified on	2018 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034350