UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of food intake and 4-week multiple curcumin ingestion on pharmacokinetics (bioavailability) of a curcumin supplement
Title of the study (Brief title)	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	Naoki Miura
Organization	Miura Clinic
Division name	Director
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	Makoto Terashima
Organization	Oneness Support Co., Ltd.
Division name	Director
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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