UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of effect of food containing plant ingredient on serum uric acid
Title of the study (Brief title)	A study of effect of food containing plant ingredient on serum uric acid
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of food containing plant ingredient on serum uric acid
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum uric acid level
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of food containing plant ingredient (Dosage 1) component food (4 weeks).
Interventions/Control_2	Ingestion of food containing plant ingredient (Dosage 2) component food (4 weeks).
Interventions/Control_3	Ingestion of food not-containing plant ingredient (4 weeks)
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 and Female
Key inclusion criteria	1)Japanese subjects of both sexes above 20 years old- under 65 years old at the point of obtaining informed consent 2)Subjects with serum uric acid level of fasting above 5.0 mg/dL-under7.0 mg/dL as target value at pre-inspection 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 intake health food, supplements, and medical chemical (Refer to exhibit 1 and 2 for specific example of food, supplements, and medical chemical) 2)Subjects who is ineligible for this study due to results of lifestyle questionnaires. 3)Subjects who have risk to develop allergy. 4)Subjects who are under treatment for chronic disorders, or subjects who need treatment with medication for serious disorders 5)Subjects who have serious diabetes, hepatic disorder (liver inflammation), kidney disorder, and cardiac disorder, or subjects who have history of medication for thyroid disorder, adrenal gland disorder, and other metabolic disease 6)Subject who have history of treatment for digestive system that effects on digestion absorption or have history of operation on digestive system 7)Subjects who are ineligible based on clinical laboratory test results and objective measurement prior to the start of ingestion 8)Subjects who participated in other clinical trial within 1 month prior to obtaining informed consent, or subjects who are planning to participate other clinical trial during this study 9)Subjects who performed blood withdrawal or component blood donation of 200 mL within 1 month or over 400 mL within 3 month before the date of obtaining informed consent 10)Subjects who drinks beyond proper quantity consistently 11)Subjects who can not temperance since 3 days prior to the pre-inspection or each inspection 12)Subjects who have history of treatment for drug dependency or alcohol dependency, or currently under the treatment for drug dependency or alcohol dependency 13)Subjects who are willing to become pregnant or lactation during this study 14)Subjects who work at Development and production companies for functional food 15)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Mai Mizutani
Organization	Kirin Company, Limited
Division name	Research Laboratories for Health Science & Food Technologies Research & Development Division
Address	1-17-1,Namamugi,Tsurumi-ku,Yokohama 230-8628 Japan
TEL	080-2049-5763
Email	m-mizutani@kirin.co.jp

Public contact
Name of contact person	Shigeru Imai
Organization	CROee. INC
Division name	Evidence Division
Address	2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL	03-5953-2108
Homepage URL
Email	imai@croee.com

Sponsor
Institute	CROee.INC
Institute
Department

Funding Source
Organization	Kirin Company, 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	2019 Year 01 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 22 Day
Anticipated trial start date	2018 Year 02 Month 06 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	2018 Year 03 Month 06 Day
Last modified on	2018 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036093