UMIN-CTR Clinical Trial

Basic information
Public title	A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Acronym	A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Scientific Title	A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Scientific Title:Acronym	A study to investigate the Serum uric acid level drop effect of ingesting test beverage for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to obtain evidence in the Serum uric acid level change in 4 consecutive weeks ingesting test beverage (beverage being testing) for adult male with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL by comparing to the control beverage
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum uric acid level and it's change
Key secondary outcomes	Urine creatinine, uric acid in the urine and it's change Urinary uric acid excretion, Uric acid clearance, Creatinine clearance, Uric acid excretion rate and it's change

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test beverage (4 weeks).
Interventions/Control_2	Ingestion of control beverage (4 weeks).
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	Not applicable
Gender	Male
Key inclusion criteria	1) 20 years of age or older male 2) Subjects with serum uric acid level above 7.1 mg/dL-under7.9 mg/dL at screening 3) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria	1) Subjects who are under drug treatment for hyperuricemia or gout, or subjects who are provided lifestyle guidance by medical doctor 2) Subjects who have history of gout 3) Subject who intake dairy product that is effective in lowering serum uric acid level on a daily basis 4) Subjects who in take health food that is effective in lowering serum uric acid level on daily basis 5) Subjects who exercise vigorously 6) Subjects with urinary tract infection, hepatic disorder, cardiac disorder, urinary tract stone disease, kidney disturbance, hypertension, diabetes, or subjects who have history of medication for those diseases, or subjects who are going to have medication during the study 7) Subjects with daily energy intake of over 4,000 kcal on Food Frequency Questionnaire Based on Food Group, FFQg, at the background investigation 8) Subjects with allergy to milk or soy 9) Subjects who had participated in other clinical trials within 1 month 10) Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator or investigator
Target sample size	106

Research contact person
Name of lead principal investigator	1st name Ide Middle name Last name Yumiko
Organization	Medical Corporation Chisei-kai Tokyo Center Clinic
Division name	Medical Corporation Chisei-kai Tokyo Center Clinic
Zip code	1030028
Address	Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL	07033513779
Email	nakano_satomi@tc-clinic.jp

Public contact
Name of contact person	1st name Satomi Middle name Last name Nakano
Organization	Tokyo Center Clinic
Division name	Clinical Research Center
Zip code	1030028
Address	2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL	07033513779
Homepage URL
Email	nakano_satomi@tc-clinic.jp

Sponsor
Institute	3H Medi Solution Inc.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
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	Japan Conference of Clinical Research
Address	28F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.com

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	東京センタークリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 24 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	71
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	2018 Year 07 Month 20 Day
Date of IRB	2018 Year 08 Month 24 Day
Anticipated trial start date	2018 Year 09 Month 21 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry	2019 Year 08 Month 10 Day
Date trial data considered complete	2019 Year 08 Month 16 Day
Date analysis concluded	2019 Year 09 Month 10 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 21 Day
Last modified on	2019 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038598