UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045013 |
|---|---|
| Receipt number | R000051420 |
| Scientific Title | A study examining the relationship between blood flow waveform indices and lifestyle-related disease indices |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2022/01/26 21:39:35 |
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Basic information
Public title
A study examining the relationship between blood flow waveform indices and lifestyle-related disease indices
Acronym
A study examining the relationship between blood flow waveform indices and lifestyle-related disease indices
Scientific Title
A study examining the relationship between blood flow waveform indices and lifestyle-related disease indices
Scientific Title:Acronym
A study examining the relationship between blood flow waveform indices and lifestyle-related disease indices
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Laboratory medicine | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between lifestyle-related disease indices and blood flow of skin and gingiva
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between lifestyle-related disease indices and blood flow of skin and gingiva
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin and gingival blood flow
Key secondary outcomes
Vascular function, blood pressure, electrocardiogram, pulse waves, heart sounds, cardiac output, stratum corneum water content, skin viscoelasticity, skin color, PMA Index, color of gingiva
probing pocket depth (PPD), gingival index (GI), bleeding on probing (BOP), dental plaque,
height, weight, abdominal circumference, number of red blood cells, blood pigment content, hematocrit, blood lipids, liver function, fasting blood sugar, HbA1C, urine sugar, urine protein
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
-Pregnancies
-Diseases with abnormal blood vessels
-Severe coldness
-Subjects who are participating in a study with physical load that affects the measurement results of this study
-Subjects who use sleeping pills, antiallergic drugs, analgesics, hormones, gastric acid secretion inhibitors, and other drugs for diseases
-Implants and dentures in the upper front gingiva
-Total dentures
-Subjects with wound in the measurement site of the skin
-Subjects with allergy symptoms
such as hay fever, rhinitis, atopic
dermatitis
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshinao |
| Middle name | |
| Last name | Nagashima |
Organization
Kao Corporation
Division name
Personal Healthcare Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9848
nagashima.yoshinao@kao.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Ohsugi |
Organization
Kao Corporation
Division name
Personal Healthcare Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7486
Homepage URL
ohsugi.yuko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 23 | 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
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
| 2021 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the relationship between lifestyle-related disease indices and blood flow of skin and gingiva
Management information
Registered date
| 2021 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051420
