Unique ID issued by UMIN | UMIN000053680 |
---|---|
Receipt number | R000061251 |
Scientific Title | Examination of clinical utility of autophagy indicator in Japanese: an observational study |
Date of disclosure of the study information | 2024/02/21 |
Last modified on | 2024/12/27 09:22:58 |
Examination of clinical utility of autophagy indicator in Japanese
Examination of clinical utility of autophagy indicator in Japanese
Examination of clinical utility of autophagy indicator in Japanese: an observational study
Examination of clinical utility of autophagy indicator in Japanese
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify clinical utility of autophagy indicators in healthy Japanese
Others
1. Establishment of autophagy indicators
2. To survey the relationship between autophagy indicators and biological markers
3. To survey the relationship between changes in exhaustive gene expression (RNA) in blood and blood glucose levels, insulin, and quality of life
Confirmatory
Pragmatic
Not applicable
1. Changes in exhaustive gene expression (RNA) in blood
1. Changes in blood glucose levels and insulin
*Levels before and 2, 4, and 8 hours after ingestion of load food
2. Score of World Health Organization Quality of Life (WHOQOL)-26 questionnaire
Observational
40 | years-old | <= |
49 | years-old | >= |
Male and Female
1. Japanese
2. Men or women
3. Individuals aged between 40 and 49 years
4. Healthy individuals
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who take or use medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and/or the load food related products, particularly who show allergic reactions to wheat, eggs, milk ingredients, almond, and/or soy beans
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
9. Individuals who are judged as ineligible to participate in this study by the physician
20
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.
ORTHOMEDICO Inc.
Self funding
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Waseda University
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 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 | 02 | Month | 21 | Day |
Unpublished
20
Completed
2024 | Year | 02 | Month | 14 | Day |
2024 | Year | 02 | Month | 14 | Day |
2024 | Year | 02 | Month | 21 | Day |
2024 | Year | 05 | Month | 21 | Day |
Study design: A cross-sectional study
Objective: To verify clinical utility of autophagy indicators in healthy Japanese
Recruitment method: The individuals are recruited via a website (https://www.go106.jp/) operated by ORTHOMEDICO Inc. as the contract research organization. Individuals who are interested in participating in this study and meet the eligibility will be selected.
Recruitment (scheduled) period: From February 22th, 2024, to March 21th, 2024
Evaluation items: Gene expression test {quantitative polymerase chain reaction (PCR)}, blood test, World Health Organization Quality of Life (WHOQOL)-26 questionnaire
Results: Unpublished
2024 | Year | 02 | Month | 21 | Day |
2024 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061251