UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027489 |
|---|---|
| Receipt number | R000031496 |
| Scientific Title | A study to evaluate the effect of a food containing Curcuma longa on liver function |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2017/05/25 15:19:12 |
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Basic information
Public title
A study to evaluate the effect of a food containing Curcuma longa on liver function
Acronym
A study to evaluate the effect of a food containing Curcuma longa on liver function
Scientific Title
A study to evaluate the effect of a food containing Curcuma longa on liver function
Scientific Title:Acronym
A study to evaluate the effect of a food containing Curcuma longa on liver function
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine effect of a food containing Curcuma longa for improving liver function for 8 weeks ingestion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Aspartate aminotransferase (AST) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention.
2. Alanine aminotransferase (ALT) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention.
3. Gammma glutamyltransferase (Gammma-GTP) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention.
Key secondary outcomes
1.Questionnaire survey (POMS-Brief) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention.
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test product containing low dose of Curcuma longa (5 tablets per a day; 8 weeks)
Interventions/Control_2
Oral ingestion of the test product containing high dose of Curcuma longa (5 tablets per a day; 8 weeks)
Interventions/Control_3
Oral ingestion of the test product not containing Curcuma longa (5 tablets per a day; 8 weeks)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 64 years of age
(2) Participants whose AST levels are <40 U/L and ALT levels are <45 U/L based on the results of preliminary examination
(3) Participants who have a drinking habit (>=5 days a week)
(4) Participants whose BMI are >=18 and <30 based on the results of preliminary examination
(5) ALT levels were top 48 out of the participants applying to the criteria (1) - (4)
Key exclusion criteria
(1) Participants who consecutively intake pharmaceutical or healthcare food which is possible to influence liver function
(2) Participants who consecutively intake pharmaceutical or healthcare food including Curcuma longa
(3) Participants who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(4) Participants having possibilities for emerging allergy related to the study
(5) Participants having a disease requiring regular medication or a history of serious diseases for which medication was required
(6) Participants who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) Participants who have participated in other clinical studies
(8) Participants who intend to become pregnant or lactating
(9) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
48
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 | Kawasaki Kengo |
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
| 2017 | Year | 05 | Month | 25 | 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
| 2014 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 25 | Day |
Last modified on
| 2017 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031496
