UMIN-CTR Clinical Trial

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