UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016493 |
|---|---|
| Receipt number | R000019154 |
| Scientific Title | Comparison of bioavailability of curcuminoid-containing turmeric supplements after single oral administration in humans: a double-blind, four-way crossover study |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2016/03/09 09:47:05 |
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Basic information
Public title
Comparison of bioavailability of curcuminoid-containing turmeric supplements after single oral administration in humans: a double-blind, four-way crossover study
Acronym
Comparison of oral bioavailability of turmeric supplements in humans
Scientific Title
Comparison of bioavailability of curcuminoid-containing turmeric supplements after single oral administration in humans: a double-blind, four-way crossover study
Scientific Title:Acronym
Comparison of oral bioavailability of turmeric supplements in humans
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of oral bioavailability of turmeric supplements
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentrations of curcuminoids and related pharmacokinetics parameters
Key secondary outcomes
Safety (biochemical examination of blood, medical examination by interview)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Turmeric supplement 1
Single oral dose of the supplement containing about 30 mg of curcumin
Interventions/Control_2
Turmeric supplement 2
Single oral dose of the supplement containing about 300 mg of curcumin
Interventions/Control_3
Turmeric supplement 3
Single oral dose of the supplement containing about 30 mg of curcumin
Interventions/Control_4
Turmeric supplement 4
Single oral dose of the supplement containing about 40 mg of curcumin
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
Good general condition
Body weight <= 80 kg
20<=BMI<25
Key exclusion criteria
Severe disease history
Food or drug allergy
Regular use or use within 2 weeks of turmeric-containing drugs or supplements
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
Head of clinic
Zip code
Address
9F Higashitemma Bld., 1-7-17, Higashitemma, Kita-ku, Oosaka-shi, Osaka, 530-0044
TEL
06-6135-5200
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, 530-0044
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Health Evaluation Research Office
Kobe University Hospital
Institute
Department
Personal name
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
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
| 2015 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2016 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019154
