UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051265 |
|---|---|
| Receipt number | R000058455 |
| Scientific Title | A study to confirm the reduction effect of the test food on abdominal visceral fat. -Randomized, double-blind, placebo-controlled parallel group study- |
| Date of disclosure of the study information | 2023/06/05 |
| Last modified on | 2023/12/04 11:05:08 |
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Basic information
Public title
A study to confirm the reduction effect of the test food on abdominal visceral fat. -Randomized, double-blind, placebo-controlled parallel group study-
Acronym
A study to confirm the reduction effect of the test food on abdominal visceral fat.
Scientific Title
A study to confirm the reduction effect of the test food on abdominal visceral fat. -Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym
A study to confirm the reduction effect of the test food on abdominal visceral fat.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for reduction of abdominal visceral fat when the test food for 12 weeks for healthy adult males and females with BMI of 23.0 or more and less than 30.0 kg/m2
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area
Key secondary outcomes
abdominal subcutaneous fat area, abdominal total fat area, body weight, BMI, body fat percentage, waist circumference, hip circumference, W/H ratio, triceps skinfold thickness, subscapular skinfold thickness, LDL- cholesterol, HDL- cholesterol, L/H ratio, triglyceride, glucose, HbA1c. resting energy expenditure, survey
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 test 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 and Female
Key inclusion criteria
1) Healthy Japanese males and females aged of 20-64 years
2) Subjects with BMI >=23.0 kg/m2 and <30.0 kg/m2 in screening test 1
3) Subjects with LDL-cholesterol <=159 mg/dL in screening test 1
4) Subjects who can visit on schedule days
5) Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1) Subjects who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs
2) Subjects who are under treatment of dyslipidemia, high blood pressure, or diabetes
3) Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study
4) Subjects who regularly use health foods and supplements affecting the study
5) Possible pregnancy, pregnancy, and lactation
6) Heavy drinkers
7) Subjects who have experienced feel bad mood by blood collection
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 defecate less than once a week
10) Night Rotation worker
11) Subjects who plan business trip or trip for 10 days or more a month
12) Subjects who have allergy related to the test foods
13) Subjects with claustrophobia that interferes with CT scans, subjects with metal in the CT scan measurement site due to surgery, subjects with implanted medical devices such as cardiac pacemakers, implantable cardioverter defibrillators
14) Subjects already participating in other clinical trials
15) Subjects who are ineligible due to physician's judgment
Target sample size
40
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 | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
t-ashino@ndrcenter.co.jp
Sponsor or person
Institute
New drug research center, Inc.
Institute
Department
Personal name
Funding Source
Organization
TOKIWA PHYTOCHEMICAL 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
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
| 2023 | Year | 06 | Month | 05 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058455
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