UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020858 |
|---|---|
| Receipt number | R000024067 |
| Scientific Title | A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2017/08/09 09:57:11 |
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Basic information
Public title
A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy
Acronym
Effects of Curcuma longa on liver function in healthy adults
Scientific Title
A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy
Scientific Title:Acronym
Effects of Curcuma longa on liver function in healthy adults
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine effects of 12-weeks ingestion of a food containing Curcuma longa for improving liver function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention.
[1]Aspartate aminotransferase (AST)
[2]Alanine aminotransferase (ALT)
Key secondary outcomes
At 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention.
[1]Gammma glutamyltransferase (Gammma-GTP)
[2]Questionnaire survey (POMS-Brief)
At 0, 12 weeks in the intervention.
[3]Tumor Necrosis Factor-alpha (TNF-alpha)
[4]Interleukin-6 (IL-6)
[5]C-reactive protein (CRP)
[6]Prostaglandin E2 (PGE2)
[7]Serum amyloid A protein (SAA)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test product containing Curcuma longa (3 tablets per a day; 12 weeks)
Interventions/Control_2
Oral ingestion of the test product not containing Curcuma longa (3tablets per a day; 12 weeks)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females over the age of 19 years
(2) Participants whose AST and ALT levels are <51 U/L
(3) Participants whose BMI are >=24 and <30
Key exclusion criteria
(1) Participants whose HCV antibody or HbsAg are positive
(2) Participants whose systolic blood pressure are lower than 90 mmHg
(3) Participants who are possibly pregnant, pregnant, or lactating
(4) Participants who have made a blood donation of 200 mL within the last one month prior to this study
(5) Male participants who have made a blood donation of 400 mL within the last three months prior to this study
(6) Female participants who have made a blood donation of 400 mL within the last four months prior to this study
(7) Male participants who have made a blood donation over an amout (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study
(8) Female participants who have made a blood donation over an amout (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study
(9) Participants who are participating in another clinical study or had finished another clinical study within the last four weeks
(10) Participants who have heart disease, liver disease, or kidney disease
(11) Participants who have any history of cardiovascular disease
(12) Participants who are diabetes mellitus
(13) Participants have medication or food allergy
(14) Participants who have excessive alcohol-drinking or smoking habit
(15) Participants who have extremely irregular dietary habits
(16) Participants who consecutively intake pharmaceutical or healthcare food which is possible to influence the result of this study
(17) Participants judged as unsuitable for the study by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Yamamoto |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
Address
Imoji 3-20, Itami, Hyogo
TEL
072-778-1121
Yamamoto_Yoshihiro@house-wf.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Kawasaki |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
Address
Imoji 3-20, Itami, Hyogo
TEL
072-778-1127
Homepage URL
Kawasaki_Kengo@house-wf.co.jp
Sponsor or person
Institute
House Wellness Foods Corporation Research and Development Institute
Institute
Department
Personal name
Funding Source
Organization
House Wellness Foods 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 03 | 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
Throughout the intervention period, AST and ALT levels did not differ between groups. For participants whose serum liver enzyme levels were in the borderline range, decreases in AST and ALT levels were significantly greater in the combination group than in the placebo group.
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 | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 09 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024067
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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