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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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