UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Title of the study (Brief title)	A study to evaluate the effect of decreasing serum uric acid level by ingestion of botanical ingredient-containing foods
Region	Japan

Condition
Condition	hyperuricemia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of decreasing serum uric acid level and safety by ingestion of botanical ingredient-containing foods
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum uric acid level
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Botanical ingredient-containing foods, 12 Weeks
Interventions/Control_2	Botanical ingredient-free foods, 12 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 years of age or older 2) 6.0 mg/dL <= serum uric acid level < 9.0 mg/dL 3) With no treatment. 4) Submitting the written informed consent before this study.
Key exclusion criteria	1) With gouty arthritis and gouty arthritis. 2) With high serum uric acid level (>= 8.0 mg/dL) and kidney damage, urinary stone, hypertension, ischemic cardiac disease, diabetes, metabolic syndrome. 3) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food. 4) Female in pregnancy, lactation and scheduled pregnancy period. 5) Investigator's judgment for other reason.
Target sample size	75

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0460
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Hidenori Obata
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0568
Homepage URL
Email	Hidenori_Obata@suntory.co.jp

Sponsor
Institute	New Drug Research Center, Inc.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Suntory Beer Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 23 Day
Anticipated trial start date	2015 Year 07 Month 13 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	2015 Year 07 Month 10 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021140