UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of test supplement on serum uric acid: A randomized, double blinded, placebo controlled, and parallel group comparison study
Title of the study (Brief title)	Effect of test supplement on serum uric acid
Region	Japan

Condition
Condition	Healthy male adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the effect of test supplement on serum uric acid.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum uric acid
Key secondary outcomes	Urinary excretion of uric acid, uric acid clearance, creatinine clearance, uric acid clearance/creatinine clearance ratio Subgroup analysis using serum uric acid levels and other clinical measurements

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test supplement for 12 consecutive weeks
Interventions/Control_2	Ingestion of placebo for 12 consecutive 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	65 years-old >
Gender	Male
Key inclusion criteria	1.Subjects aged from 20 to 65 years old 2. Subjects whose serum uric acid levels are included within a range of 6.0 mg/dL to 7.0 mg/dL
Key exclusion criteria	1. Subjects who usually take some medicine, foods for specified health uses, foods with function claims, health foods, or cosmetics including active ingredients 2. Subjects who have been taking foods affecting the study results once a week or more 3. Subjects who have gout in the past or are currently receiving treatment for hyperuricemia or gout (including exercise therapy, dietary guidance) 4. Subjects who are under treatment or have history of diseases (urinary stone, kidney stone, rheumatoid arthritis) which may influence the outcome of the study 5. Subjects who routinely use analgesics (non-steroidal analgesics, steroidal analgesics, etc.). 6.Subjects who habitually do intense exercise such as marathon 7. Subjects who cannot carry out the procedures of various inspections to be carried out during the research as specified (24 hour urine collection etc) 8. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication therapy 9. Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) 10. Subjects with allergies to the test food in the study 11. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 12. Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 13. Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire 14. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	80

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	Yoshiki Shimizu
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Homepage URL
Email	shimizu_yoshiki@fancl.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
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	医療法人健昌会　福島健康管理センター いきいきクリニック メディカルステーションクリニック 医療法人社団絆 アーバンハイツクリニック

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 23 Day
Anticipated trial start date	2017 Year 03 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 03 Month 27 Day
Last modified on	2017 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030649