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 |
A study to improve cognitive function by the ONO-SR/AST-SOYPC intake
A study to improve cognitive function by the ONO-SR/AST-SOYPC intake
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
A study to improve cognitive function by the ONO-SR/AST-SOYPC intake
Japan |
Healthy Japanese adults
Not applicable | Adult |
Others
NO
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
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The standardized score of composite memory at 12 weeks after consumption (12w)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Prevention
Food |
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
Duration: 12 weeks
Test food: Capsule not containing salmon roe oil
Administration: Take four capsules with water without chewing after meals
50 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
100
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
ONO PHARMACEUTICAL CO.,LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
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)
2024 | Year | 07 | Month | 21 | Day |
Unpublished
110
Completed
2022 | Year | 11 | Month | 16 | Day |
2022 | Year | 11 | Month | 16 | Day |
2022 | Year | 12 | Month | 20 | Day |
2023 | Year | 07 | Month | 22 | Day |
2022 | Year | 12 | Month | 20 | Day |
2024 | Year | 04 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056770
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |