UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020251
Receipt number R000023381
Scientific Title Internal organs fat decrease effect confirmation examination in long-term aging vinegar "KOZU" (Double-blind study)
Date of disclosure of the study information 2016/01/10
Last modified on 2016/11/01 09:37:07

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Basic information

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

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

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


Public contact

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


Sponsor or person

Institute

Kojun Japan co.,ltd.

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 10 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

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name