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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030087
Receipt No. R000034350
Scientific Title Examination on the action of botanical extracts on brain functions
Date of disclosure of the study information 2017/11/22
Last modified on 2018/04/18

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Basic information
Public title Examination on the action of botanical extracts on brain functions
Acronym Examination on the action of botanical extracts on brain functions
Scientific Title Examination on the action of botanical extracts on brain functions
Scientific Title:Acronym 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
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
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
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
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)

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
2017 Year 11 Month 22 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 Completed
Date of protocol fixation
2017 Year 10 Month 13 Day
Date of IRB
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

Other
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

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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