UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024771 |
|---|---|
| Receipt number | R000028418 |
| Scientific Title | Effect of supplements containing fermented black garlic on hepatic function - a parallel randomized trial-. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/11/03 12:25:27 |
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Basic information
Public title
Effect of supplements containing fermented black garlic on hepatic function - a parallel randomized trial-.
Acronym
Effect of fermented black garlic on hepatic function.
Scientific Title
Effect of supplements containing fermented black garlic on hepatic function - a parallel randomized trial-.
Scientific Title:Acronym
Effect of fermented black garlic on hepatic function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of supplements containing fermented black garlic on hepatic functions of healthy Japanese
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hepatic function (AST, ALT, LD, gamma-GTP, LAP)
Key secondary outcomes
Renal function (Urea nitrogen, Creatine, Uric acid)
Sugar metabolism (glucose, HbA1c)
Lipid metabolism (HDL-cholesterol, LDL-cholesterol, Triglycerides)
Physical measurements (Body weight, Body fat percentage, waist circumference, systolic blood pressure, diastolic blood pressure, heart beat)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Capsule containing fermented black garlic
334 mg of the garlic/day
Interventions/Control_2
Placebo capsule not containing fermented black garlic
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) persons who is generally judged as healthy
(2) persons who feel change in their body shapes and/or disturbance of the life
Key exclusion criteria
(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) persons who have changed their habitats to take supplements within past 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) persons who have been treated their illness or prevention in a clinic at their informed consent
(5) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) persons with the medical histories of alcoholism or drug dependence
(7) persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) persons who will not be judged suitable to the participants by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniyoshi Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
Address
6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN
TEL
092-642-3002
shimizu@agr.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniyoshi Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
Address
6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN
TEL
092-642-3002
Homepage URL
shimizu@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Miraikan Co. Ltd.,
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Humanity-Oriented Science and Engineering, Kindai University
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 | 12 | 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 | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028418
