UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048790 |
|---|---|
| Receipt number | R000055587 |
| Scientific Title | Saliva metabolome study in human: an observational study |
| Date of disclosure of the study information | 2022/08/30 |
| Last modified on | 2023/05/09 13:13:53 |
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Basic information
Public title
Saliva metabolome study in human
Acronym
Saliva metabolome study in human
Scientific Title
Saliva metabolome study in human: an observational study
Scientific Title:Acronym
Saliva metabolome study in human
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore candidate molecules of biomarkers in saliva by investigating the relationship between sleep quality and the saliva metabolite in healthy adult subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Metabolome analysis and multiple testing corrections (q-value)
Key secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI) Japanese version and the St. Mary's Hospital sleep questionnaire (SMH)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese
2. Men
3. Subjects aged 45 or more and less than 60
4. Healthy subjects
5. Subjects who work a five-day week
6. Subjects who meet the above inclusion criteria (1. to 5.) and meet the below criteria (a. or b.) (*A total of 160 subjects {80 subjects in each criterion (a. or b.)} will be selected)
a. Subjects who are concerned about their sleep quality
b. Subjects who are not concerned about their sleep quality
7. Subjects who meet the above inclusion criteria (1. to 6.) and meet the below criteria (c. or d.) based on the results of PSQI in the screening observation period (*A total of 22 subjects {11 subjects in each criterion (c. or d.)} will be selected)
c. Subjects whose score of PSQI is two or less
d. Subjects whose score of PSQI is six or more
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medications
7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in this study by the physician
Target sample size
22
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
National Institute of Advanced Industrial Science and Technology
Organization
Division
Category of Funding Organization
Other
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
| 2022 | Year | 08 | Month | 30 | 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
22
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 | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A cross-sectional study
Objectives: To explore candidate molecules of biomarkers in saliva by investigating the relationship between sleep quality and the saliva metabolite in healthy adult subjects
Recruitment method: The subjects are recruited via a website (https://www.go106.jp/) operated by ORTHOMEDICO Inc. as the contract research organization. Subjects who are interested in participating in this study and meet the eligibility will be selected.
Recruitment (scheduled) period: From August 25th, 2022, to September 16th, 2022
Assessment items: Metabolome analysis, multiple testing corrections (q-value), the Pittsburgh Sleep Quality Index (PSQI), and the St. Mary's Hospital sleep questionnaire (SMH)
Results: Unpublished
Management information
Registered date
| 2022 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055587
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