UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000040466