UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of trial supplement on serum uric acid level -A double blind, placebo controlled study-
Title of the study (Brief title)	Effect of ingestion of trial supplement on serum uric acid level
Region	Japan

Condition
Condition	Healthy male subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	This study is aimed to verify improvement effect of trial supplement on serum uric acid level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum uric acid level
Key secondary outcomes	Urine uric acid level Subgroup analysis using SNP Relationship among serum uric acid, urine uric acid, and SNP

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of trial supplement A for 4 weeks
Interventions/Control_2	Ingestion of trial supplement B for 4 weeks
Interventions/Control_3	Ingestion of trial supplement C for 4 weeks
Interventions/Control_4	Ingestion of placebo for 4 weeks
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
Key inclusion criteria	1) Japanese males aged from 20 to less than 65 years old. 2) Subjects whose serum uric acid levels are included within 6.0mg/dL and 8.0mg/dL.
Key exclusion criteria	1) Subjects who are under treatment or have a history of hyperuricemia or gout. 2) Subjects who have a history of gouty arthritis or gouty arthritis. 3) Subjects who are under treatment or have a history of rheumatoid arthritis. 4) Subjects who have a history of urinary stone or kidney stone. 5) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor 6) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease. 7) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of serum uric acid. 8) Subjects who routinely use or are planned to use analgesics (non-steroidal analgesics, steroidal analgesics, etc.). 9) Subjects with allergies to the products used in the study. 10) Subjects who are planned to change their lifestyle. 11) Subjects who have participated in other clinical study within the last one month prior to the current study 12) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	40

Research contact person
Name of lead principal investigator	Kumie Ito
Organization	Nihonbashi Sakura Clinic
Division name	Assistant director
Address	5F,Inamura Building,1-9-2, Nihonbashikayabacho,Chuo-ku, Tokyo, Japan
TEL	03-6661-9061
Email	k-ito@ouryokukai.jp

Public contact
Name of contact person	Yoshiki Shimizu
Organization	FANCL CORPORATION
Division name	Research institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3755
Homepage URL
Email	shimizu_yoshiki@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	医療法人社団桜緑会 日本橋さくらクリニック

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 17 Day
Anticipated trial start date	2016 Year 08 Month 21 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	2016 Year 08 Month 18 Day
Last modified on	2017 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027258