UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for decreasing effects of yogurt containing Lactobacillus gasseri PA-3 on the serum uric acid levels
Title of the study (Brief title)	A study for decreasing effects of yogurt on the serum uric acid levels
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the influence of successive intake of yogurt containing Lactobacillus gasseri PA-3 on the serum uric acid levels.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum uric acid level and change
Key secondary outcomes	1) AST(GOT), ALT(GPT),gamma-GTP, ALP, LDH, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride , urea nitrogen, serum creatinine, blood sugar, HbA1c, Na, Cl, K and change 2) urine creatinine, urine uric acid and change 3) body weight, BMI and change 4) blood pressure, pulse rate and change 5) the amount of urinary excretion of uric acid, uric acid clearance, creatinine clearance, the rate of urinary excretion of uric acid and change

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
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	Consumption of yogurt containing Lactobacillus gasseri PA-3 for 8 weeks
Interventions/Control_2	Consumption of yogurt without Lactobacillus gasseri PA-3 for 8 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	Not applicable
Gender	Male
Key inclusion criteria	1) Male subjects aged twenty or more 2) Subjects who have a serum uric acid level of 5.0 mg / dL or more and 7.0 mg / dL or less for screening 1st and 2nd 3) Subjects who can understand the purpose and the contents of this study, and can agree to participation to this study by letter
Key exclusion criteria	1) Subjects who are instructed pharmacotherapy for hyperuricemia or gout or life guidance by physician 2) Subjects who have the past medical history of gout 3) Subjects who routinely take Meiji Probio Yogurt PA-3 4) Subjects who routinely take health food effective for reducing serum uric acid levels 5) Subjects who routinely intensive exercises 6) Among subjects who have or have a history of urinary tract infections, liver diseases, heart diseases, urolithiasis, renal disorders, hypertension, diabetes mellitus, subjects who are undergoing pharmacotherapy or who are planning to receive pharmacotherapy during the study 7) Subjects who are routinely unbalanced on dietary habits 8) Subjects who show allergic responses to dairy products 9) Subjects who have participated in other clinical tests within the past one month 10) Subjects who were judged inadequate by investigator for other reasons
Target sample size	240

Research contact person
Name of lead principal investigator	Kazue Kogina
Organization	Nihonbashi Kakigara Cho Clinic
Division name	internal medicine
Address	MIYATA Building 2F, 1-10-4 Nihonbashikakigara-cho, Chuo-ku, Tokyo
TEL	03-5651-1361
Email	kaki.cl@heiikukai.jp

Public contact
Name of contact person	Masanori Ito
Organization	Mebix, Inc.
Division name	Research Promotion Group
Address	TORANOMON TOWERS OFFICE 14F, 4-1-28 Toranomon, Minato-ku, Tokyo
TEL	03-4362-4507
Homepage URL
Email	yogurt-pa3@mebix.co.jp

Sponsor
Institute	Nihonbashi Kakigara Cho Clinic
Institute
Department

Funding Source
Organization	Meiji 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	2016 Year 11 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2016 Year 11 Month 18 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 11 Month 16 Day
Last modified on	2017 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028619