UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of oral administration of probiotic LKM512 and arginine on function of vascular endothelium in individuals with pre-metabolic syndrome
Title of the study (Brief title)	Effects of probiotic LKM512 and arginine on function of vascular endothelium
Region	Japan

Condition
Condition	pre-metabolic syndrome
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of oral administration of probiotic LKM512 and arginine on function of vascular endothelium in patients with pre-metabolic syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	RH-PAT(Endo-PAT)
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	The volunteer were given an 8-week treatment with oral administration of bifidobacteria LKM512 powder (6 billion bacterial cells/stick) and 3 arginine tablets (100mg/tablet) two times per day.
Interventions/Control_2	The volunteer were given an 8-week treatment with oral administration of placebo powder without bifidobacteria LKM512 and 3 placebo tablets without arginine two times per 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	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Outpatients whose BMl is more than 25.0
Key exclusion criteria	1. Outpatients whose BMl is more than 25.0 2. Subjects who take a medicine for dyslipidemia treatment 3. Serious subjects who have complications with cardiac disease, hepatic disease,and/or renal disease 4. Subjects who had serious gastrointestinal disease in the past 5. Subjects who take hypotensive medicines 6. Subjects who have serious constipation 7. Subjects who was enrolled in other trails within one month 8. Inappropriate cases evaluated by doctors
Target sample size	40

Research contact person
Name of lead principal investigator	Mitsuharu Matsumoto
Organization	Kyodo Milk Industry Co. Ltd.
Division name	Research Laboratories
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	Satoshi Sakurai
Organization	imeQ CO. Ltd.
Division name	CRO division
Address	a vous primus Bld, 2-14-6, nishiwaseda, Shinjuku-ku, Tokyo 169-0075
TEL	03-6279-3591
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)

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	2014 Year 10 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 11 Day
Anticipated trial start date	2014 Year 10 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 06 Day
Last modified on	2018 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017848