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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043602
Receipt No. R000049733
Scientific Title Evaluation of cognitive function by continuous intake of food containing fermented soybean extract
Date of disclosure of the study information 2021/03/12
Last modified on 2021/05/11

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Basic information
Public title Evaluation of cognitive function by continuous intake of food containing fermented soybean extract
Acronym Evaluation of cognitive function by continuous intake of food containing fermented soybean extract
Scientific Title Evaluation of cognitive function by continuous intake of food containing fermented soybean extract
Scientific Title:Acronym Evaluation of cognitive function by continuous intake of food containing fermented soybean extract
Region
Japan

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

Objectives
Narrative objectives1 To study the effects of foods containing fermented soybean extract on cognitive function in healthy Japanese men and women between the ages of 40 and 65 by having them consume the foods continuously.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitrax
Key secondary outcomes (Secondary outcomes)
Subjective symptoms questionnaire
(Safety evaluation)
Vital signs,Body Measurement Values,Biochemistry,Hematology,Urinalysis,Adverse events

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 12-weeks intake of the test food
Interventions/Control_2 12-weeks 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Japanese men and women aged between 40 and 65 at the time of obtaining written informed consent.
2.Subject who is aware of the decline in cognitive function.
3.Subject who has a MMSE-J score of 24 points or more.
4.Non-smoker.
5.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the study after understanding it well, and agreed to participate in the study in writing.
Key exclusion criteria 1.Subject who is taking medication or under medical treatment.
2.Subject who is under exercise therapy or dietetic therapy.
3.Subject who may develop allergies due to the test foods.
4.Subject with current or history of drug dependence or alcohol dependence.
5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past.
6.Subject with irregular life rhythms due to night shifts or shift work.
7.Subject with extremely irregular lifestyle habits such as eating and sleeping.
8.Subject who has an extremely unbalanced diet.
9.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have.
10.Subject who uses health foods, supplements(Ginkgo biloba extract, DHA, EPA, plasmaprogen, phosphatidylserine, etc.), and medicines that have an affect cognitive function.
11.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plans to participate in other clinical trials (research) during the trial period.
12.Subject who has collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition.
13.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
14.Subject who has difficulty observing records on various survey forms.
15.Subject who is judged as an inappropriate candidate according to the screening data.
16.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Email ochitani@huma-rd.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization TOYO HAKKO 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 Ethics Committees of Yoga Allergy Clinic
Address 4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel 03-5491-4478
Email jim@medipharma.co.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 03 Month 12 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 No longer recruiting
Date of protocol fixation
2021 Year 02 Month 26 Day
Date of IRB
2021 Year 03 Month 12 Day
Anticipated trial start date
2021 Year 03 Month 15 Day
Last follow-up date
2021 Year 08 Month 06 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 03 Month 12 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049733

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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