UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035518 |
|---|---|
| Receipt number | R000040466 |
| Scientific Title | Pilot study of the metabolism of sphingolipids and other small metabolites in blood and urine after oral intake of konjac ceramides |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/01/16 16:11:57 |
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Basic information
Public title
Pilot study of the metabolism of sphingolipids and other small metabolites in blood and urine after oral intake of konjac ceramides
Acronym
Metabolism of sphingolipids and metabolites after oral intake of konjac ceramides
Scientific Title
Pilot study of the metabolism of sphingolipids and other small metabolites in blood and urine after oral intake of konjac ceramides
Scientific Title:Acronym
Metabolism of sphingolipids and metabolites after oral intake of konjac ceramides
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ceramides is one of the main constituents of epidermis to create the barrier functions of skin as well as moisturizing effects. Ceramides are contained rich in konjac, but it is not clear how the ceramides in konjac is metabolized after oral intake. The purpose of this study is to elucidate the pathway of ceramide absorption after oral intake and to evaluate the impact on the metabolisms of sphingolipids and other small metabolites in blood and urine.
Basic objectives2
Others
Basic objectives -Others
This study is basic medical science to evaluate the metabolism of sphingolipids, but contains intervention to healthy volunteers in the forms of ceramide oral intake.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative analysis of sphingolipids by targeted analysis using liquid chromatography-mass spectrometry.
Key secondary outcomes
Qualitative analysis of small metabolites by u targeted analysis using liquid chromatography-mass spectrometry.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Single intake of konjac ceramide tablet and observation of metabolites before and after the intake every 6 hours for 24 hours, and continuous intake of konjac ceramide tablet for 3 months and observation of metabolites before and after the intake every 2 weeks for 3 months.
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
healthy volunteers without any diseases under treatment.
Key exclusion criteria
Persons who are under clinical treatment for any kinds of diseases.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideru Obinata |
Organization
Gunma University
Division name
Gunma University Initiative for Advance Research
Zip code
Address
Showa-machi 3-39-22, Maebashi, Gunma
TEL
027-220-7908
obi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideru Obinata |
Organization
Gunma University
Division name
Gunma University Initiative for Advance Research
Zip code
Address
Showa-machi 3-39-22, Maebashi, Gunma
TEL
027-220-7908
Homepage URL
obi-tky@umin.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040466
