UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating the effect of the test food on serum uric acid of adult males
Title of the study (Brief title)	Evaluating the effect of the test food on serum uric acid of adult males
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the 8-week intake of the test food on serum uric acid of males aged 20 to 64 years
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum uric acid
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the test food for 8 weeks
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	64 years-old >=
Gender	Male
Key inclusion criteria	(1)Males aged 20 to 64 years (2)Serum uric acid 5.5-7.0 mg/dL
Key exclusion criteria	(1)Subjects who routinely use health food richly containing nobiletin (2)Subjects currently undergoing treatment with hyperuricemia and/or gout (3)Subjects having renal impairment and /or urinary stone (4)Subjects currently undergoing treatment with serious hepatic dysfunction (5)Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required (6)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (7)Subjects having possibilities for emerging allergy related to the study (8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10)Subjects who have participated in other clinical studies when this study started (11)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	16

Research contact person
Name of lead principal investigator	Norikuni Yamamoto
Organization	OkinawaHam Savoury Food Company
Division name	Quality Control Development Department
Address	2822-3 Zakimi, Yomitan-son, Okinawa
TEL	098-958-4330
Email	dpd@okiham.co.jp

Public contact
Name of contact person	Etsushi Yamamoto
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	e.yamamoto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

Funding Source
Organization	OkinawaHam Savoury Food Company
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	2016 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 09 Month 01 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027523