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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041225
Receipt No. R000047077
Scientific Title Exploratory study of food material on abdominal visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Date of disclosure of the study information 2020/07/28
Last modified on 2020/07/27

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Basic information
Public title Exploratory study of food material on abdominal visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Acronym Exploratory study of food material on abdominal visceral fat
Scientific Title Exploratory study of food material on abdominal visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym Exploratory study of food material on abdominal visceral fat
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of intake of food material for 12 weeks on abdominal fat area reduction and safety in males with abdominal obesity aged 20-64
Basic objectives2 Safety,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, Body weight, BMI, Body fat percentage, Waist circumference, blood pressures (systolic and diastolic),AST(GOT),ALT(GPT),gamma-GT, total cholesterol, HDL- cholesterol, LDL- cholesterol triglyceride, glucose,sample size estimation




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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of study food for 12 weeks
Interventions/Control_2 Intake of placebo food 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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male
Key inclusion criteria 1)Males equal to or more than 20 years and less than 65 years
2)Subjects with BMI >=25 kg/m2 and <30 kg/m2
3)Subjects who visit on schedule days
4)Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria 1)Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
2)Subjects who dyslipidemia, high blood pressure, diabetes
3)Subjects who use drugs affecting lipid metabolism, blood pressure or carbohydrate metabolism
4)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study
5)Subjects who regularly use drugs, health foods, and supplements affecting the study
6)Heavy dinker
7)Subjects who feel bad mood by blood collection in past
8)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period
9)Subjects who have been constipated for more than 5 days
10)Shift worker
11)Subjects who plan business trip or trip for 10 days or more a month
12)Subjects who have allergy related to the study foods
13)Subjects already participating in other clinical trials
14)Subjects who are ineligible due to physician's judgment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ikuo
Middle name
Last name Fukuhara
Organization Fukuhara Clinic
Division name Hospital director
Zip code 061-1351
Address 3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL 0123-36-8029
Email i-feniwa@gray.plala.or.jp

Public contact
Name of contact person
1st name Tomoya
Middle name
Last name Yuhki
Organization New drug research center, Inc.
Division name Clinical Research Dept.
Zip code 061-1405
Address 452-1 Toiso, Eniwa-shi, Hokkaido, Japan
TEL 0123-34-0412
Homepage URL
Email t-yuhki@ndrcenter.co.jp

Sponsor
Institute Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals 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 Fukuhara Clinic Clinical Trial Review Committee
Address 1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido
Tel 0123-36-8029
Email d-kameda@mediffom.co.jp

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
2020 Year 07 Month 28 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
2020 Year 07 Month 14 Day
Anticipated trial start date
2020 Year 08 Month 27 Day
Last follow-up date
2020 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047077

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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