UMIN-CTR Clinical Trial

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

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Serum uric acid
Key secondary outcomes	Urinary uric acid

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing plant ingredient, 1 food
Interventions/Control_2	Food not containing plant ingredient, 1 food
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 and Female
Key inclusion criteria	(1)(Healthy) individuals who are the age of 20 to less than the age of 65 years old. (2)Individuals whose fasting serum uric acid levels are from 6.0 mg/dL to 7.0 mg/dL. (3)Individuals giving written informed consent.
Key exclusion criteria	(1)Individuals who use oral medication or supplements or functional foods affecting uric acid metabolism. (2)Individuals who is not suitable for subjects by pre-test questionnaire. (3)Individuals who declare the allergy symptoms against test diets. (4)Individuals who have a chronic disease and use medicines continuously. (5)Individuals who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (6)Individuals who have a history of digestive disease affecting digestion and absorption. (7)Individuals who are judged as unsuitable for the study based on the results of blood test. (8)Individuals who are planned to participate in other clinical study. (9)Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study. (10)Individuals with excessive alcohol-drinking behaviors (over 20 g alcohol/day). (11)Individuals who can't stop drinking for 3 days until the pre-check day and check days. (12)Individuals who is diagnosed as severe anemia and not suitable for frequent collection of blood. (13)Individuals who have under treatment or a history of drug addiction and/or alcoholism. (14)Individuals who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (15)Individuals who are working for a functional food company. (16)Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	20

Research contact person
Name of lead principal investigator	Jiro Saito
Organization	Medical station clinic
Division name	Medical station clinic
Address	3-12-8 Takaban Meguro-ku, Tokyo
TEL	03-6271-9140
Email	j.saito@med-station.jp

Public contact
Name of contact person	Teruo Saito
Organization	TTC Co., Ltd
Division name	Site Management Organization Division
Address	1-10-10 Ebisu-nishi, Shibuya-ku, Tokyo
TEL	03-6455-0880
Homepage URL
Email	t.saito@ttc-smo.jp

Sponsor
Institute	TTC Corporation
Institute
Department

Funding Source
Organization	Kirin Co., Ltd.
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	2017 Year 04 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 28 Day
Anticipated trial start date	2016 Year 03 Month 29 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	Protocol No. 27055

Management information
Registered date	2016 Year 03 Month 15 Day
Last modified on	2017 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024778