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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043242
Receipt No. R000049350
Scientific Title Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Date of disclosure of the study information 2021/02/13
Last modified on 2021/02/04

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Basic information
Public title Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Acronym Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Scientific Title Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Scientific Title:Acronym Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and effect of continuous intake of test food on cognitive function in male and female with cognitive decline between the ages of 60 and 80.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MMSE
Key secondary outcomes Cognitive function test (eye gaze test), BDNF, IGF-1, IGFBP-3, questionnaire (VAS, QOL)

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 Take 1 packet of test food daily with water after breakfast for 12 weeks
Interventions/Control_2 Take 1 packet of placebo food daily with water after breakfast for 12 weeks
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Aged 60 to 80 years old at the time of informed consent.
2. Japanese male and female
3. Those who have subjective symptoms of cognitive decline and are judged by the investigators to have no problem participating in the study
4. Those who can input their own data into the electronic diary
5. Those who can provide written consent
Key exclusion criteria 1. receiving any types of medicines and/or Chinese medical treatment (Abortive use is acceptable)
2. current or history of serious diseases such as liver, kidney, heart, respiratory organs, endocrinology, and metabolic diseases
3. possible allergic symptoms to the test food
4. score of 23 or less on the Cognitive Function Test (MMSE)
5. experience of taking a neuropsychological test at a hospital, etc.
6. taking health foods (foods or supplements for the purpose of maintaining or recovering health)
7. current or history of drug and/or food allergies
8. participation in another clinical trial within one month before providing consent, participating currently or planning to participate
9. excessive consumption of alcohol (alcohol equivalent 60g or more / day)
10. excessive smoking habits (21 or more cigarettes / day)
11. judged by the investigator to be unsuitable for participating in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshie
Middle name
Last name Tokuta
Organization JELLICE CO., LTD.
Division name Produvtion & Development group Technical center
Zip code 985-0833
Address 4-4-1 Sakae Tagajo-city Miyagi
TEL 022-361-8821
Email y.tokuta@jellice.com

Public contact
Name of contact person
1st name Hirokuni
Middle name
Last name Kayama
Organization imeQ RD inc.
Division name Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo
TEL 03-6704-5968
Homepage URL
Email h-kayama@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

Funding Source
Organization JELLICE 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 Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-3207-8161
Email suda-clinic_irb@imeq.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 02 Month 13 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
2020 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 14 Day
Last follow-up date
2021 Year 06 Month 09 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 04 Day
Last modified on
2021 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049350

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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