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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029142
Receipt No. R000033318
Scientific Title Examination on an effect of improving cognitive function by intake of a test food product
Date of disclosure of the study information 2017/12/20
Last modified on 2018/03/01

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Basic information
Public title Examination on an effect of improving cognitive function by intake of a test food product
Acronym Examination on an effect of improving cognitive function by intake of a test food product
Scientific Title Examination on an effect of improving cognitive function by intake of a test food product
Scientific Title:Acronym Examination on an effect of improving cognitive function by intake of a test food product
Region
Japan

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

Objectives
Narrative objectives1 To examine an influence of a test food product on cognitive function in Japanese males and females aged 50 and over, below 70 who are aware of a decline in the cognitive function, and assign them to take the test food product for 12 weeks on a continuous basis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax,MMSE
Key secondary outcomes Hematologic test, blood biochemical test, vital signs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 12-week intake of the test food
Interventions/Control_2 12-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.Those who are aware of a decline in cognitive function
4.Those who can take 9 capsules a day for 12 weeks on a continuous basis
5.MMSE score of 22 or higher
6.Non-smoker
Key exclusion criteria 1.Currently in treatment with medication or seeing a doctor for treatment
2.Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications
3.Previous history of drug allergy or food allergy
4.Regular intake of a food product or supplements with a possible influence on cognitive function
5.Regular intake of drug with a possible influence on cognitive function
6.Extreme faddiness
7.Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
8.Suspicion of insomnia
9.Presence or previous history of mental disorder (depression, etc.)
10.Presence or previous history of alcoholism
11.Current participation in another clinical trial or participation in another clinical trial within the last three months
12.Irregular work hours such as working on night shift
13.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size 62

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takihara Takanobu
Organization ITO EN, Ltd.
Division name Central Research Institute
Zip code
Address 21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL 0548-54-1247
Email t-takihara@itoen.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 ITO EN,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 12 Month 20 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 08 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 14 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033318

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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