UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Internal organs fat decrease effect confirmation examination in long-term aging vinegar "KOZU" (Double-blind study)
Title of the study (Brief title)	Internal organs fat decrease effect confirmation examination in vinegar "KOZU" (NKJ-1 study)
Region	Japan

Condition
Condition	BMI value is higher Japanese
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To target a monitor that is definition and BMI increased , to confirm the effect of reducing visceral fat when it is allowed to continue ingestion of the test substance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area of the abdomen (Intervention before 4 weeks , before the start , after 12 weeks)
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	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects(long-term aged vineger"KOZU") eat 15mL/day for 12 weeks
Interventions/Control_2	The subjects(short-term aged vineger"KOZU") eat 15mL/day for 12 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

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)The healthy person who does not have a serious disease 2)And wish to voluntarily participate in a clinical trial following 60 years of age or 30 years of age , who written consent is obtained 3)Who can ingest the vinegar 4)BMI (Body Mass Index) of 23 or more , of less than 30 persons 5)Who can maintain the daily life weekly during the test period at a constant
Key exclusion criteria	1)Diabetes, heart disease, kidney disease, liver disease, those who have a medication for the treatment of hypertension such as 2)Severe disease (cancer, heart disease, kidney disease, etc.) A person with a history of 3)A person more than three times the reference value upper limit of liver function and renal function test values 4)Persons with food allergies and drug allergy related to the food test 5)Those who have had surgery of the digestive tract 6)Those who have regular specified health food and functional food display related to the cholesterol blood sugar suppress and bowel movement improvement (indigestible dextrin, plant sterols, chitosan, those including psyllium seed coat) a 7)Those persons and in the diet to the violent sport 8)Those who are participating in other clinical trials within the past one month 9)Hot flashes, dizziness, there are subjective symptoms of menopause symptoms of sweating like a person 10)Persons under postmenopausal three years 11)Who you are wearing a pacemaker 12)Those who participate in the study investigator were disqualified
Target sample size	40

Research contact person
Name of lead principal investigator	Hiromu Katsuta
Organization	Relife-inc
Division name	Clinical Development Division
Address	Koshin BLD 501 1-47-1 Higashi-Ikebukuro Toshima-ku Tokyo
TEL	03-5928-2501
Email	hkatsuta@relife-inc.com

Public contact
Name of contact person	Hiromu Katsuta
Organization	Relife-inc
Division name	Clinical Development Division
Address	Koshin BLD 501 1-47-1 Higashi-Ikebukuro Toshima-ku Tokyo
TEL	03-5928-2501
Homepage URL
Email	hkatsuta@relife-inc.com

Sponsor
Institute	Kojun Japan co.,ltd.
Institute
Department

Funding Source
Organization	Kojun Japan 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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 01 Month 15 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	2015 Year 12 Month 17 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023381