UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Nihonbashi Kakigara Cho Clinic

Institute

Department

Personal name

Organization

Meiji Co.,ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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