UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024866 |
|---|---|
| Receipt number | 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 16:50:56 |
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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
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
yogurt-pa3@mebix.co.jp
Sponsor or person
Institute
Nihonbashi Kakigara Cho Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028619
