UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021069 |
|---|---|
| Receipt number | R000024306 |
| Scientific Title | Placebo-controlled double-blinded parallel randomized study to test the urate-lowering effect of yogurt containing Lactobacillus gasseri PA-3 in adult males with marginal hyperuricemia |
| Date of disclosure of the study information | 2016/02/17 |
| Last modified on | 2016/02/17 14:25:40 |
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Basic information
Public title
Placebo-controlled double-blinded parallel randomized study to test the urate-lowering effect of yogurt containing Lactobacillus gasseri PA-3 in adult males with marginal hyperuricemia
Acronym
A study on the effect of the yogurt containing Lactobacillus gasseri PA-3 on uric acid level.
Scientific Title
Placebo-controlled double-blinded parallel randomized study to test the urate-lowering effect of yogurt containing Lactobacillus gasseri PA-3 in adult males with marginal hyperuricemia
Scientific Title:Acronym
A study on the effect of the yogurt containing Lactobacillus gasseri PA-3 on uric acid level.
Region
| Japan |
Condition
Condition
Healthy male adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the Lactobacillus gasseri PA-3 on uric acid level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum uric acid level
Key secondary outcomes
Urine uric acid level
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A 85g Yogurt non-containing Luctobacillus gasseri PA-3 is give for 8 weeks
Interventions/Control_2
A 85g Yogurt low-concentration Luctobacillus gasseri PA-3 give for 8 weeks
Interventions/Control_3
A 85g Yogurt hight-concentration Luctobacillus gasseri PA-3 give for 8 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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.
2.Subjects who meets the following condition at the time of a check before absorption.
1)35years of age or older male
2)Serum uric acid level are 6.0mg/dL over.
Key exclusion criteria
1.Subjects with Phamacotherapy,Exercise therapy and Medical diet of hyperuricemia(gout).
2.Subjects with a history of gout or hyperuricemia.
3.Subjects with a using healthy food about hyperuricemia commonly.
4.Subjects who are judged ineligible by the principal investigator or subinvestigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Sekine |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Clinicall Management Department
Zip code
Address
1-21-16 kannondai,tsukuba city,Ibarakii 305-0856,Japan
TEL
029-839-1150
m-sekine@tsukuba-icp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Mochii |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Clinicall Management Department
Zip code
Address
1-21-16 kannondai,tsukuba city,Ibarakii 305-0856,Japan
TEL
029-839-1150
Homepage URL
m-mochii@tsukuba-icp.jp
Sponsor or person
Institute
Tsukuba International Clinical Pharmacology 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
つくば国際臨床薬理クリニック（茨城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 17 | 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
The results of the analysis after excluding the data with purine intake of over 450 mg/day have shown that serum urate of the high-concentration group was significantly lower than the placebo group at week 2 (P = 0.025), and the linear regression analysis has indicated a dose-dependent decrease of serum urate ( P = 0.046). The equivalent analysis using the data at week 8 also showed that serum urate of the high-concentration group was significantly lower than the placebo group (P = 0.031), and the linear regression analysis indicated a dose-dependent decrease of serum urate ( P = 0.021). Those data suggest that yogurt containing L. gasseri PA-3 lower serum urate.
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
| 2012 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 17 | Day |
Last modified on
| 2016 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024306
