UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025802 |
|---|---|
| Receipt number | 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 18:59:11 |
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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
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
mizuki1604@fancl.co.jp
Sponsor or person
Institute
FANCL
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
