UMIN-CTR Clinical Trial

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
Email	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
Email	ohsugi.yuko@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051420