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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031545
Receipt No. 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

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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
Institute New drug research center, Inc.
Institute
Department

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
URL(English) https://upload.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


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