UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041225 |
|---|---|
| Receipt number | 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 | 2021/02/15 17:52:08 |
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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
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
t-yuhki@ndrcenter.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047077
