UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the inspection process for the oxidation and glycation diagnosis
Title of the study (Brief title)	A study to evaluate the inspection process for the oxidation and glycation diagnosis
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the usefulness of the test method for diagnosing oxidation and glycation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Correlation of skin AGE accumulation amount calculated for each device [2]Correlation of blood special examination (AP, OS, pentosidin, CML), CML in stratum corneum and accumulation amount of skin AGEs
Key secondary outcomes

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Aged between 20 and 99 [2]Individuals who are healthy and do not treat any disease [3]Individuals whose written informed consent has been obtained [4]Individuals who can have an examination on a designated check day [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.) [3]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease [4]Individuals judged inappropriate for the study by the principal
Target sample size	100

Research contact person
Name of lead principal investigator	Yuji Morita
Organization	SQOL Kanazawa/Urata clinic
Division name	Anti-aging research center
Address	3-3-70,Hirooka,Kanazawa-City,Ishikawa,JAPAN
TEL	076-233-6020
Email	morita@hospy.jp

Public contact
Name of contact person	Yuji Morita
Organization	SQOL Kanazawa/Urata clinic
Division name	Anti-aging research center
Address	3-3-70,Hirooka,Kanazawa-City,Ishikawa,JAPAN
TEL	076-233-6020
Homepage URL
Email	morita@hospy.jp

Sponsor
Institute	SQOL Kanazawa/Urata clinic
Institute
Department

Funding Source
Organization	SQOL Kanazawa/Urata clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Glycation Stress Research Center,Faculty of Life and Medical Sciences,Doshisha University
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	For healthy men and women aged 20 years and under 100, subject background investigation (questionnaire form), Measurement by height / weight / body fat percentage / BMI,skin AGEs accumulation amount measuring machine (AGE Reader su, AGE Reader mu, TruAge, TruAge mini, AGE sensor), general blood / biochemical examination, blood special inspection (antioxidant: AP, Oxidation degree: OS, pentosidine, CML), CML measurement in the stratum corneum by the tape stripping method is carried out.

Management information
Registered date	2018 Year 02 Month 16 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035764