UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026198 |
|---|---|
| Receipt number | R000030096 |
| Scientific Title | Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2017/11/02 11:03:06 |
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Basic information
Public title
Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.
Acronym
Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.
Scientific Title
Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.
Scientific Title:Acronym
Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.
Region
| Japan |
Condition
Condition
Healthy male subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of present study is to evaluate the effects of melinjo seed extract powder on the level of serum uric acid and research its effective dose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum uric acid level
(at 2-3 weeks and 1 day before the intervention, and after 4, 8, 12 weeks of daily intake.)
Key secondary outcomes
blood test, urinalysis
(at 2-3 weeks and 1 day before the intervention, and after 4, 8, 12 weeks of daily intake.)
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral administration of melinjo seed extract powder (100mg/day, 12weeks)
Interventions/Control_2
Oral administration of melinjo seed extract powder (200mg/day, 12weeks)
Interventions/Control_3
Oral administration of melinjo seed extract powder (300mg/day, 12weeks)
Interventions/Control_4
Oral administration of placebo (everyday, 12weeks)
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
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
[1] Male subjects whose serum uric acid level is between 6.0 mg/dL and 6.9 mg/dL, and age is between 20 and 69 years old.
Key exclusion criteria
[1] Taking drugs that may affect serum uric acid level.
[2] Individuals who can't stop taking supplement and functional food that may affect serum uric acid level during the test peripd.
[3] Individuals who have an infection needed systemic therapy.
[4] Individuals who are considered that participation for this trial is difficult because of psychiatric symptoms or psychosis.
[5] Individuals who have a uncontrollable diabetes millutus or requiring administration of insulin.
[6] Individuals who are sensitive to test products.
[7] AST >150U/L.
[8] ALT >150U/L.
[9] Total bilirubin >2.0mg/dL.
[10] Individuals who have a kidney disease.
[11] Individuals who have or had a severe allergy or asthma.
[12] Individuals who have a disease needing immediate treatment or serious complication.
[13] Individuals with a digestive organ disease or surgical history having an influence on digestive absorption.
[14] Individuals who have an anamnesis or a history of present illness of drug dependence or alcohol dependence.
[15] Individuals who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that.
[16] Individuals who suffer from gout.
[17] Individuals judged inappropriate for participating the study by the principal
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Kishi |
Organization
Jin-ai University
Division name
Faculty of Human Life Studies, Department of Health and Nutrition.
Zip code
Address
3-1-1, Ohde-cho, Echizen-shi, Fukui-ken 915-8568, Japan
TEL
0778-27-2010
skishi@jindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Sakamoto |
Organization
Research Center for Immunological Analysis, Inc.
Division name
none
Zip code
Address
Okayama Research Park Incubation Center 213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama, 701-1221, Ja
TEL
086-286-9333
Homepage URL
info@menekibunseki.com
Sponsor or person
Institute
Research Center for Immunological Analysis, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Hosoda Shc co.,Ltd
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
| 2018 | Year | 07 | 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 | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | 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
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030096
