UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031545
Receipt number R000036020
Scientific Title Visceral fat-reducing effect of food containing the milk-derived ingredient
Date of disclosure of the study information 2018/03/02
Last modified on 2019/03/04 09:15:46

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Basic information

Public title

Visceral fat-reducing effect of food containing the milk-derived ingredient

Acronym

Visceral fat-reducing effect of food containing the milk-derived ingredient

Scientific Title

Visceral fat-reducing effect of food containing the milk-derived ingredient

Scientific Title:Acronym

Visceral fat-reducing effect of food containing the milk-derived ingredient

Region

Japan


Condition

Condition

No (healthy adults)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the visceral fat-reducing effect of food containing the milk-derived ingredient

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visceral fat area

Key secondary outcomes

Subcutaneous fat area, Total fat area, Waist circumference, Hip circumference, Body weight, BMI


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

Food containing the milk-derived ingredient, 12 weeks

Interventions/Control_2

Food non-containing the milk-derived ingredient, 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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Japanese males and females aged 20 to 64 years old at the time of acquiring consent.
(2) Subjects whose BMI are 23 to 29.9 at the screening test.
(3) Subjects with visceral fat areas of more than 70 cm2 at the screening test.
(4) Subjects who provided written informed consent.

Key exclusion criteria

(1) Subjects with the metabolic syndrome.
(2) Subjects who have taken medication or surgery due to serious illness or injury within one month before the start of the study.
(3) Subjects who have serious diseases in the heart, liver, kidney or digestive organs in the present or past.
(4) Subjects who take a medicine for hyperglycemia, hyperlipidemia or hypertension.
(5) Subjects who regularly use drugs or functional foods affecting the study.
(6) Subjects who are pregnant or lactating.
(7) Heavy drinkers or heavy smokers.
(8) Subjects with milk allergy.
(9) Subjects who are judged as unsuitable for the study by the investigator for the other reason.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ikuo Fukuhara

Organization

Fukuhara Clinic

Division name

Director

Zip code


Address

3-1-15, Shima-matsuhigashi machi, Eniwa-shi, Hokkaido, Japan

TEL

0123-36-8029

Email

i-feniwa@gray.plala.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shimpei Tomita

Organization

New drug research center, Inc.

Division name

Clinical Research Dept.

Zip code


Address

452-1, Toiso, Eniwa-shi, Hokkaido, Japan

TEL

0123-34-0412

Homepage URL


Email

s-tomita@ndrcenter.co.jp


Sponsor or person

Institute

New drug research center, Inc.

Institute

Department

Personal name



Funding Source

Organization

LION Corporation

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

福原医院(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 02 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

2018 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 06 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

2018 Year 03 Month 02 Day

Last modified on

2019 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name