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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024866
Receipt No. R000028619
Scientific Title A study for decreasing effects of yogurt containing Lactobacillus gasseri PA-3 on the serum uric acid levels
Date of disclosure of the study information 2016/11/16
Last modified on 2017/11/17

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Basic information
Public title A study for decreasing effects of yogurt containing Lactobacillus gasseri PA-3 on the serum uric acid levels
Acronym A study for decreasing effects of yogurt on the serum uric acid levels
Scientific Title A study for decreasing effects of yogurt containing Lactobacillus gasseri PA-3 on the serum uric acid levels
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazue Kogina
Organization Nihonbashi Kakigara Cho Clinic
Division name internal medicine
Zip code
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
1st name
Middle name
Last name Masanori Ito
Organization Mebix, Inc.
Division name Research Promotion Group
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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