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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025802
Receipt No. R000029672
Scientific Title Clinical trial of controlled-release function by gelling agent in food.
Date of disclosure of the study information 2017/01/23
Last modified on 2017/07/25

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Basic information
Public title Clinical trial of controlled-release function by gelling agent in food.
Acronym Clinical trial of controlled-release function by gelling agent in food.
Scientific Title Clinical trial of controlled-release function by gelling agent in food.
Scientific Title:Acronym Clinical trial of controlled-release function by gelling agent in food.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the conrolled-release function bygelling agent in food.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes AUC,Cmax and Tmax of blood curcumin and blood tetrahydrocurcumin.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Curcumin jelly 1
Single ingestion 15 g
Interventions/Control_2 Curcumin jelly 2
Single ingestion 15 g
Interventions/Control_3 Curcumin jelly 3
Single ingestion 15 g
Interventions/Control_4 Curcumin drink
Single ingestion 15 g
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1)The healthy men and women less than 50 years old more than 20 years old.
2)BMI >=18.5 kg/m*m and <25 kg/m*m.
Key exclusion criteria 1) Subjects who are difficulty of over time the blood collection.
2) Subjects who are taking medicine or being treated by a doctor.
3) Subjects who previous or present serious disease such hemopathy, circulatory, breathing, liver, kidney or digestive system disease.
4) Subjects who are participating or planning to participate in other clinical study.
5) Subjects who cannot stop taking healthy food from one week before to the end of the test period.
6) Subjects who are taking healthy food containing turmeric.
7) Subjects who cannot stop taking of turmeric food from 3 days before to the end of test day.
8) Subjects who may cause allergic to turmeric.
9) Women who are pregnant or breast-feeding.
10) Subjects who are judged as unsuitable for this study by study director.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayuri Matsuoka
Organization FANCL Corporation
Division name Research Institute
Zip code
Address Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL 045-820-3522
Email matsuoka@fancl.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mizuki Watanabe
Organization FANCL Corporation
Division name Research Institute
Zip code
Address Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa,244-0806
TEL 045-820-3659
Homepage URL
Email mizuki1604@fancl.co.jp

Sponsor
Institute FANCL
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
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 ファンケル総合研究所/FANCL Reseach Instite

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 23 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 Completed
Date of protocol fixation
2017 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 23 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029672

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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