UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049842 |
|---|---|
| Receipt number | R000056770 |
| Scientific Title | An evaluation study of the improving effects of intake of ONO-SR/AST-SOYPC on cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/07/21 |
| Last modified on | 2024/04/16 09:17:16 |
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Basic information
Public title
A study to improve cognitive function by the ONO-SR/AST-SOYPC intake
Acronym
A study to improve cognitive function by the ONO-SR/AST-SOYPC intake
Scientific Title
An evaluation study of the improving effects of intake of ONO-SR/AST-SOYPC on cognitive function: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A study to improve cognitive function by the ONO-SR/AST-SOYPC intake
Region
| Japan |
Condition
Condition
Healthy Japanese adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to confirm the effects of consuming this test food on cognitive function and quality of life (QOL) in men or women aged between 50 and 80, and noticed a cognitive function decline
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The standardized score of composite memory at 12 weeks after consumption (12w)
Key secondary outcomes
1. The standardized scores of cognitive function tests (except for composite memory) at 12w
2. The Profile of Mood States 2nd Edition (POMS2) at 12w
3. Plasma cortisol at 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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: ONO-SR/AST-SOYPC (containing salmon roe oil, astaxanthin and soy lecithin)
Administration: Take four capsules with water without chewing after meals
Interventions/Control_2
Duration: 12 weeks
Test food: Capsule not containing salmon roe oil
Administration: Take four capsules with water without chewing after meals
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Men or women aged between 50 and 80
4. Healthy subjects
5. Subjects whose scoring of Mini Mental State Examination (MMSE) is between 24 and 28
6. Subjects who have relatively low standardized score in composite memory measured using Cognitrax
7. Subjects having a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory
8. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
Subjects who
1.have a pacemaker or an implantable cardioverter defibrillator
2.have COVID-19
3.have a past medical history (PMH) of malignant tumor, heart failure, and myocardial infarction
4.are undergoing treatment for chronic diseases (e.g. atrial fibrillation, arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, gastrointestinal disorder)
5.have a PMH or current medical history (CMH) of psychosis, dementia, cranial nerve diseases, or cerebrovascular diseases
6.have depressive symptoms/have been diagnosed with depression
7.usually take medicines, herbal medicines, and supplements (Foods for Specified Health Uses, or Foods with Functional Claims)
8.take health foods with rich e.g. DHA, EPA or blue-backed fish (e.g. sardines, mackerel, and saury) at least 4 times a week
9.consecutively take medicines or health foods that may influence the results (e.g. ginkgo leaf extract, tocotrienol, astaxanthin, GABA, phosphatidylserine, and plasmalogen) at least a week
10.have difficulty performing cognitive tests due to poor eyesight or hearing
11.have a CMH of menopausal symptoms
12.have a PMH or CMH of drug or alcohol dependence
13.will have an irregular life due to e.g. night shifts twice or more during this trial
14.are smokers/have quit smoking within 12 months before the pre-consumption assessment (0w)
15.donated 200 or 400 mL of whole blood/had a blood transfusion within 3 months before 0w
16.are judged as ineligible to participate from laboratory values or measurement at 0w
17.are judged as ineligible to participate from lifestyle questionnaires
18.are allergic to medicines or test food related products
19.have a PMH of atopic dermatitis
20.are pregnant/lactating/will be pregnant during this trial
21.have been enrolled in other clinical trials within 28 days before agreeing to participate or plan to participate another trial during this trial
22.are judged as ineligible to participate by the physician
Target sample size
100
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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL 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
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
| 2024 | Year | 07 | Month | 21 | 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
110
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
| 2022 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056770
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