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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023857
Receipt No. 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

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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
Institute Kyodo Milk Industry Co. Ltd.
Institute
Department

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
URL(English) https://upload.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


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