UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052954 |
|---|---|
| Receipt number | R000060413 |
| Scientific Title | A dose-ranging study to confirm the reduction effect of plant extract on body fat. -Randomized, double-blind, placebo-controlled parallel group study- |
| Date of disclosure of the study information | 2023/11/30 |
| Last modified on | 2024/11/05 14:17:23 |
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Basic information
Public title
A dose-ranging study to confirm the reduction effect of plant extract on body fat. -Randomized, double-blind, placebo-controlled parallel group study-
Acronym
A dose-ranging study to confirm the reduction effect of plant extract on body fat.
Scientific Title
A dose-ranging study to confirm the reduction effect of plant extract on body fat. -Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym
A dose-ranging study to confirm the reduction effect of plant extract on body fat.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of plant extract intake on body fat area.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
abdominal total fat area (amount of change)
Key secondary outcomes
abdominal total fat area (measured value),
abdominal visceral fat area, abdominal subcutaneous fat area, body weight, body mass index (BMI), body fat percentage, muscle mass (overall), waist circumference, hip circumference, femoral circumference, upper arm circumference, insulin, CRP, adiponectin, leptin (measured value and amount of change)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1 for 12 weeks
Interventions/Control_2
Intake of test food 2 for 12 weeks
Interventions/Control_3
Intake of placebo food for 12 weeks
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
3) Subjects who can visit the study institution on schedule days
4) Subjects who recognize the object and content of the study and have given their consent in writing before the study begins
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 this study
5) Possible pregnancy, pregnancy, and lactation
6) Heavy drinkers, excessive smokers
7) Subjects who have experienced feel bad mood by blood collection
8) Subjects with systolic blood pressure less than 90 mmHg
9) Subjects who donated 200 mL or more of blood within 1 month from the start of this study or those who plan to do so during this study
10) Subjects who have been diagnosed with chronic constipation
11) Shift workers or late-night workers
12) Subjects who plan business trip or trip on average more than 10 days per month
13) Subjects who may have allergy to the ingredients contained in the test food
14) Subjects who are participating in other clinical trials, those who plan to participate during this study, and those within 1 month after the trial in which they participated
15) Subjects whose exercise habits may change significantly, those who regularly engage in strenuous exercise and those who on a diet
16) Subjects with extremely irregular eating habits
17) 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
18) Subjects who fail to comply with the requests to subjects during the study period
19) Subjects who are ineligible due to physician's judgment
Target sample size
75
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
Morishita Jintan 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 | 11 | Month | 30 | 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
78
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
| 2023 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060413
