UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.
Title of the study (Brief title)	Evaluation of the effects of melinjo seed extract powder on the level of serum uric acid.
Region	Japan

Condition
Condition	hyperuricemia
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	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral administration of melinjo seed extract powder (300mg/day, 12weeks)
Interventions/Control_2
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	70 years-old >
Gender	Male
Key inclusion criteria	[1] Male subjects whose serum uric acid level is between 7.0 mg/dL and 7.9 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	20

Research contact person
Name of lead principal investigator	Shinji Kishi
Organization	Jin-ai University
Division name	Faculty of Human Life Studies, Department of Health and Nutrition.
Address	3-1-1, Ohde-cho, Echizen-shi, Fukui-ken 915-8568, Japan
TEL	0778-27-2010
Email	skishi@jindai.ac.jp

Public contact
Name of contact person	Tatsuya Sakamoto
Organization	Research Center for Immunological Analysis, Inc.
Division name	none
Address	Okayama Research Park Incubation Center 213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama, 701-1221, Ja
TEL	086-286-9333
Homepage URL
Email	info@menekibunseki.com

Sponsor
Institute	Research Center for Immunological Analysis, Inc.
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 24 Day
Anticipated trial start date	2017 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 28 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030260