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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042446
Receipt No. R000048453
Scientific Title A verification study for improving cognitive function with consumption of the test food in healthy subjects: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/17

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Basic information
Public title A verification study for improving cognitive function with consumption of the test food in healthy subjects
Acronym A verification study for improving cognitive function with consumption of the test food in healthy subjects
Scientific Title A verification study for improving cognitive function with consumption of the test food in healthy subjects: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym A verification study for improving cognitive function with consumption of the test food in healthy subjects
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of consumption of the test food on cognitive function in healthy subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The measured values of the standardized score of composite memory of Cognitrax at 12 weeks after consumption (12w)
Key secondary outcomes 1. The measured values of the standardized score of composite memory of Cognitrax at four and eight weeks after consumption (4w, 8w)

2. The amount of change of the standardized score of composite memory of Cognitrax between screening (before consumption; Scr) and 4w, 8w, or 12w

3. The measured values and amounts of changes from Scr of the standardized scores of Neurocognition Index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention, and motor speed of Cognitrax at 4w, 8w, and 12w

4. The measured values and amounts of changes from Scr of total score of self-administered dementia checklist and the scores of "subjective cognitive decline" and "subjective decline in daily living functioning" at 4w, 8w, and 12w

5. The measured values of all of the items of self-administered dementia checklist at 4, 8, and 12w

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: Nounai Kakusan
Administration: Take eight tablets with water at any time during the day

*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test food: Placebo
Administration: Take eight tablets with water at any time during the day

*If you forget to take the test food, take it as soon as you remember within the day.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese subjects aged 40 or more

2. Subjects who are aware of the decline in their memory function

3. Subjects who are judged as eligible to participate in the study by the physician

4. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory

5. Subjects who have 24 points or more of MMSE

6. Subjects who have a relatively low standardized score in composite memory by Cognitrax
Key exclusion criteria 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

4. Subjects who have dementia

5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

6. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

7. Subjects who take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen in daily use

8. Subjects who regularly take blue-backed fish such as sardines, mackerel, and saury

9. Subjects who regularly use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games)

10. Currently taking medicines (include herbal medicines) and supplements

11. Subjects who are allergic to medicines and/or the test food related products, especially to salmon, milk, or soy

12. Subjects who are pregnant, breast-feeding, or planning to become pregnant

13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period

14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization MAINICHIGENKI. CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-clinic.com

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 11 Day
Date of IRB
2020 Year 11 Month 11 Day
Anticipated trial start date
2020 Year 11 Month 17 Day
Last follow-up date
2021 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 13 Day
Last modified on
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048453

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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