UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053021 |
|---|---|
| Receipt number | R000060484 |
| Scientific Title | Saliva metabolome study in human: an observational study |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2024/12/27 09:22:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Metabolome analysis (omega Scan 100 samples, quantification of 353 substances)
Key secondary outcomes
1. Salivary protein
2. The value of the Pittsburgh Sleep Quality Index (PSQI) {PSQI global score (PSQIG), "Sleep quality", "Sleep latency", "Sleep duration", "Habitual sleep efficiency", "Sleep disturbance", "Use of sleeping medication", and "Daytime dysfunction"}
3. The value of the OSA sleep inventory MA version (OSA-MA) {"Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in OSA-MA}
4. The value of the Profile of Mood States 2nd Edition (POMS2) Japanese version {Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F), Total Mood Disturbance (TMD), and each item in POMS2}
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. Male
3. Middle age (45 years or older and less than 60 years old)
4. Healthy individuals
5. Individuals who work continuously for five days in a complete two-day weekend system
6. Individuals who meet the above inclusion criteria (1. to 5.) and meet the below criteria (a. or b.) (*A total of 730 individuals {365 individuals in each criterion (a. or b.)} will be selected)
a. Individuals who are concerned about their sleep quality
b. Individuals who are not concerned about their sleep quality
7. Individuals 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 period (*A total of 100 individuals {50 individuals in each criterion (c. or d.)} will be selected)
c. Individuals whose score of PSQI (PSQIG) is two or less
d. Individuals whose score of PSQI (PSQIG) is six or more
Key exclusion criteria
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 are taking medications (including herbal medicines) and supplements
6. Individuals who are allergic to medications
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 or plan to participate another study during this study
9. Individuals who are judged as ineligible to participate in this study 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
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 Bldg., 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
| 2023 | Year | 12 | Month | 06 | 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
100
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
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 03 | 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
Objective: To explore candidate molecules of biomarkers in saliva by investigating the relationship between sleep quality and the saliva metabolite in healthy adult
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 December 6th, 2023, to January 23th, 2024
Evaluation items: saliva test (metabolome analysis, salivary protein measurement), PSQI, OSA-MA, POMS2
Results: Unpublished
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060484
