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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043348
Receipt No. R000049493
Scientific Title A study of the effects of test food on cognitive function -A randomized, double-blind, placebo-controlled, parallel study
Date of disclosure of the study information 2021/02/17
Last modified on 2021/02/17

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Basic information
Public title A study of the effects of test food on cognitive function -A randomized, double-blind, placebo-controlled, parallel study
Acronym A study of the effects on cognitive function
Scientific Title A study of the effects of test food on cognitive function -A randomized, double-blind, placebo-controlled, parallel study
Scientific Title:Acronym A study of the effects on cognitive function
Region
Japan

Condition
Condition Healthy subjects(including MCI)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the effects of test food on cognitive function and Its Safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of cognitive function by Cognitrax test and eye tracking at 0 week and at 6,12 weeks
Key secondary outcomes

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral intake of the test foods (high dose) (8 capsules in a day for 12 weeks)
Interventions/Control_2 Oral intake of the test foods (low dose) (8 capsules in a day for 12 weeks)
Interventions/Control_3 Oral intake of the placebo foods (8 capsules in a day for 12 weeks)
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy subjects with MMSE results by screening test of 24 points or more(including MCI)
2) Healthy adults aged 40 to 70 years old.
3) Gender: No preference
4) Subjects without smoking habits
5) Subjects who do not have a habit of taking a meal containing a large amount of the tested food
6) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases
7) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction
8) Subjects who have no history of allergy to test foods / medicines
9) Subjects who do not take medication for Outpatient treatment
10) Subjects who do not regularly use health foods
11) Subjects giving written informed consent
Key exclusion criteria 1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study
3) Subjects who do not comply with instructions from the doctor or medical staff
4) Others who have been determined ineligible by investigator
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Naotaka
Middle name
Last name Hashiya
Organization Kanyukai clinic
Division name Head
Zip code 553- 0004
Address 2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
TEL 06-6444-7788
Email hashiya@carna-medsalon.jp

Public contact
Name of contact person
1st name Taisuke
Middle name
Last name Fukaya
Organization Tashikani Plus Co., Ltd
Division name CEO
Zip code 530-0041
Address 6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
TEL 06-6352-6622
Homepage URL
Email fukaya@tashikani.jp

Sponsor
Institute Tashikani Plus Co., Ltd
Institute
Department

Funding Source
Organization non-disclosure
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 Japan Food Evidence Association
Address 7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
Tel 06-6352-6622
Email info@food-evidence.jp

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
2021 Year 02 Month 17 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 16 Day
Date of IRB
2021 Year 02 Month 16 Day
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 17 Day
Last modified on
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049493

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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