UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023857
Receipt number R000027430
Scientific Title A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of yogurt containing probiotic LKM512 and arginine on function of vascular endothelium and intestinal environment
Date of disclosure of the study information 2016/08/31
Last modified on 2019/06/11 18:47:50

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Basic information

Public title

A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of yogurt containing probiotic LKM512 and arginine on function of vascular endothelium and intestinal environment

Acronym

Effects of yogurt containing probiotic LKM512 and arginine on function of vascular endothelium

Scientific Title

A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of yogurt containing probiotic LKM512 and arginine on function of vascular endothelium and intestinal environment

Scientific Title:Acronym

Effects of yogurt containing probiotic LKM512 and arginine on function of vascular endothelium

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of yogurt containing probiotic LKM512 and arginine on function of vascular endothelium in healthy adults

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

RH-PAT(Endo-PAT)

Key secondary outcomes

Blood biomarker, BMI, Systolic blood pressure, Diastolic blood pressure, Abdominal girth, Analyses of fecal samples


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The volunteer were given a 12-week treatment with 100g yogurt containing bifidobacteria LKM512 (10 billion bacterial cells/100g) and arginine (600mg/100g) once a day.

Interventions/Control_2

The volunteer were given a 12-week treatment with 100g yogurt without bifidobacteria LKM512 and arginine once a day.

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

30 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

The individuals whose BMl is under 30

Key exclusion criteria

1. Subjects who take a medicine, or visit the hospital for some disease
2. Subjects who had serious gastrointestinal disease, and subjects who had surgery of the digestive tract in the past
3. Subjects who was enrolled in other trails within one month, and female subjects who are, might become pregnant, or lactating
4. Subjects who have food allergies
5. Inappropriate cases evaluated by doctors

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuharu Matsumoto

Organization

Kyodo Milk Industry Co. Ltd.

Division name

Research Laboratories

Zip code


Address

20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182

TEL

042-597-5911

Email

m-matumoto@meito.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Sakurai

Organization

imeQ CO. Ltd.

Division name

CRO division

Zip code


Address

a vous primus Bld, 2-14-6, nishiwaseda, Shinjuku-ku, Tokyo 169-0075

TEL

03-6205-6222

Homepage URL


Email

s-sakurai@imeq.co.jp


Sponsor or person

Institute

Kyodo Milk Industry Co. Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kyodo Milk Industry 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

医療法人社団 札幌百合の会病院 (北海道)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 31 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 08 Month 26 Day

Date of IRB

2016 Year 08 Month 29 Day

Anticipated trial start date

2016 Year 09 Month 05 Day

Last follow-up date

2016 Year 12 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 02 Month 24 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 31 Day

Last modified on

2019 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name