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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021406
Receipt No. R000024690
Scientific Title Effects of food intake and 4-week multiple curcumin ingestion on pharmacokinetics (bioavailability) of a curcumin supplement
Date of disclosure of the study information 2016/11/01
Last modified on 2016/09/21

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Basic information
Public title Effects of food intake and 4-week multiple curcumin ingestion on pharmacokinetics (bioavailability) of a curcumin supplement
Acronym Pharmacokinetics (bioavailability)
of of a curcumin supplement
Scientific Title Effects of food intake and 4-week multiple curcumin ingestion on pharmacokinetics (bioavailability) of a curcumin supplement
Scientific Title:Acronym Pharmacokinetics (bioavailability)
of of a curcumin supplement
Region
Japan

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

Objectives
Narrative objectives1 Effects of food intake of 4-week multiple ingestion of curcumin on bioavailability of a curcumin supplement
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Pharmacokinetics parameters
(AUC, Cmax, baseline plasma curcumin concetration)
Key secondary outcomes MDA, 8-OHdG, metabolome

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Curcumin supplement
Single oral dose of the supplement containing 30 mg of curcumin, twice a day for 4 weeks
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
45 years-old >=
Gender Male and Female
Key inclusion criteria - Subjects signed on informed consent documents

- Healthy male and female Japanese subjects at the age between 20 and 45

- Non-smoker

- Body weight <= 80 kg

- 20<=BMI<25

- Subjects whoeat 3 meals a day regulary
Key exclusion criteria - Severe disease history

- Currently under treatment

- Food or drug allergy

- Regular use of curcumin-containing supplements

- Pregnant or planned on becoming pregnant

- Other unappropriate conditions judged by PI
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Miura
Organization Miura Clinic
Division name Director
Zip code
Address 9F Higashitemma Bld., 1-7-17, Higashitemma, Kita-ku, Oosaka-shi, Osaka, 530-0044
TEL 06-6135-5200
Email miura@miura-cl.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Terashima
Organization Oneness Support Co., Ltd.
Division name Director
Zip code
Address 8F Higashitemma Bld., 1-7-17, Higashitemma, Kita-ku, Oosaka-shi, Osaka
TEL 06-4801-8917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Kobe University Hospital
Center for Clinical Research
Health Evaluation Research Office
Institute
Department

Funding Source
Organization Association for Health Economics Research and Social Insurance and Welfare
Organization
Division
Category of Funding Organization Non profit foundation
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
2016 Year 11 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 Completed
Date of protocol fixation
2016 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 23 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 15 Day
Date trial data considered complete
2016 Year 08 Month 20 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 09 Day
Last modified on
2016 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024690

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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