UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049951 |
|---|---|
| Receipt number | R000056891 |
| Scientific Title | Self-controlled, open-label, pre/post comparison study of functional supplements to characterize changes in SAF and study on population with reduced SAF |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/01/01 11:11:57 |
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Basic information
Public title
Study on reduction of skin autofluorescence (SAF) by various supplements
Acronym
Decrease in SAF by taking supplements
Scientific Title
Self-controlled, open-label, pre/post comparison study of functional supplements to characterize changes in SAF and study on population with reduced SAF
Scientific Title:Acronym
Research on individuals showing reduction of SAF by taking supplements
Region
| Japan |
Condition
Condition
Advanced glycation end-products
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Individualized study of response to supplements in subjects with elevated SAF value
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the difference between the mean SAF at the end of the last week (week 20) of supplementation and the mean SAF during the previous observation period (1-2 weeks) in individual subjects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Hydrogen-releasing supplements for 20 weeks or
Reduced form of CoQ10 for 20 weeks or
Foods containing Salacia ingredients for 20 weeks or
Foods containing mulberry leaf ingredients for 20 weeks or
Foods containing mangosteen ingredients for 20 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have at least 1 S.D. above the mean SAF for the subject's age at the time of screening prior to obtaining consent
2. Those who are 20 years-old or older at the time of obtaining consent
3. Those who have given their free written consent after receiving sufficient explanation for participation in this research
Key exclusion criteria
1. Those who are below the SAF average for the subject's age, or those who are above the average but below 1 S.D. at the time of screening prior to obtaining consent
2. Those who have a SAF value variation of more than plus/minus 0.2 a.u. from the SAF value at screening during the previous observation period
3. Those who are 70 years-old or older, BMI 30 or higher, and current smoker at the time of consent
4. Those who suspected alcohol or caffeine addiction
5. Those who with extremely irregular lifestyle
6. Those who have history of cardiovascular disease (males only), diabetes mellitus, or renal failure (on dialysis)
7. Patients with severe renal disease (more than BUN 25 mg/dL or serum creatinine 2.0 mg/dL)
8. Patients with severe liver disease (more than AST (GOT) or ALT (GPT) 100 U)
9. Pregnant or possibly pregnant or lactating women
10. Those who are drug addiction
11. Individuals who are deemed inappropriate as research participants by the principal investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Noritaka |
| Middle name | |
| Last name | Ariyoshi |
Organization
Okayama University
Division name
Facylty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6619
ariyoshi-n@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Noritaka |
| Middle name | |
| Last name | Ariyoshi |
Organization
Okayama University
Division name
Faculty of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6619
Homepage URL
pmaphs.ou@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Faculty of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2023 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 01 | Day |
Last modified on
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056891
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
