UMIN-CTR Clinical Trial

Public title

Internal organs fat decrease effect confirmation examination in long-term aging vinegar "KOZU" (Double-blind study)

Acronym

Internal organs fat decrease effect confirmation examination in vinegar "KOZU" (NKJ-1 study)

Scientific Title

Internal organs fat decrease effect confirmation examination in long-term aging vinegar "KOZU" (Double-blind study)

Scientific Title:Acronym

Internal organs fat decrease effect confirmation examination in vinegar "KOZU" (NKJ-1 study)

Region

Japan

Condition

BMI value is higher Japanese

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Visceral fat area of the abdomen (Intervention before 4 weeks , before the start , after 12 weeks)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiromu Katsuta

Organization

Relife-inc

Division name

Clinical Development Division

Zip code

Address

Koshin BLD 501 1-47-1 Higashi-Ikebukuro Toshima-ku Tokyo

TEL

03-5928-2501

Email

hkatsuta@relife-inc.com

Name of contact person

1st name
Middle name
Last name	Hiromu Katsuta

Organization

Relife-inc

Division name

Clinical Development Division

Zip code

Address

Koshin BLD 501 1-47-1 Higashi-Ikebukuro Toshima-ku Tokyo

TEL

03-5928-2501

Homepage URL

Email

hkatsuta@relife-inc.com

Institute

Kojun Japan co.,ltd.

Institute

Department

Personal name

Organization

Kojun Japan co.,ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

11

Month

30

Day

Date of IRB

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

Other related information

Registered date

2015

Year

12

Month

17

Day

Last modified on

2016

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023381