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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035518
Receipt No. 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

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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
Email 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
Email obi-tky@umin.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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