UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057248 |
|---|---|
| Receipt number | R000065420 |
| Scientific Title | Study of the effects of Peucedanum japonicum root extract on abdominal fat reduction -Randomized, double-blind, placebo-controlled, parallel group study- |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2026/04/27 14:23:57 |
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Basic information
Public title
Study of the effects of Peucedanum japonicum root extract on abdominal fat reduction
-Randomized, double-blind, placebo-controlled, parallel group study-
Acronym
Study of the effects of Peucedanum japonicum root extract on abdominal fat reduction
Scientific Title
Study of the effects of Peucedanum japonicum root extract on abdominal fat reduction
-Randomized, double-blind, placebo-controlled, parallel group study-
Scientific Title:Acronym
Study of the effects of Peucedanum japonicum root extract on abdominal fat reduction
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate for effects of abdominal fat reduction when supplementing with Peucedanum japonicum root extract or placebo for 12 weeks in healthy adult males and females with high BMI who take a lot of fat
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, waist circumference, hip circumference, waist circumference/hip circumference, total cholesterol, LDL- cholesterol, HDL- cholesterol, triglyceride, glucose, HbA1c
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 active 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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese males and females aged 20 to 39 years-old
2)Participants with a BMI >=23 and < 30 in screening test
3)Participants who are judged to take a lot of fat according to the FFQg in the preliminary investigation
4)Participants who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study based on good understanding, and have agreed to participate in the study in writing
Key exclusion criteria
1)Participants who are under treatment of severe illness in the liver, kidney, digestive organs, heart, respiratory, endocrine, thyroid, adrenal, or other metabolic
2)Participants who are implanted with a cardiac pacemaker or a defibrillator
3)Participants who are implanted with metal in the CT scan measurement area
4)Claustrophobic
5)Participants who have food allergies
6)Participants who have gastrointestinal diseases or a history of gastrointestinal surgery that affects digestion and absorption (excluding appendicitis)
7)Participants who have a history or current condition of drug or alcohol dependence
8)Smorkers
9)Participants using medications that may affect obesity, hyperglycemia, hyperlipidemia, or lipid metabolism
10)Participants who cannot refrain from consuming health foods or supplements that may affect obesity, hyperglycemia, hyperlipidemia, or lipid metabolism during the study period
11)Participants who regularly use intestinal regulator or laxatives(excluding who can stop using in the study period )
12)Participants who cannot abstain from alcohol from the day before each test until the end of the test
13)Participants who drink more than approximately 40 g/day of pure alcohol on four or more days a week
14)Participants who are judged to be muscular in the screening test
15)Participants who are ineligible due to physician's judgment in the screening test
16)Participants who are judged to have chronic constipation in the preliminary investigation
17)Participants who have donated more than 200 mL of blood and/or component blood within one month or more than 400 mL within three months of consent in this study
18)Participants who feel bad mood by blood collect
19) Participants who have extremely irregular eating habits or are shift workers or night workers.
20)Pregnancy, lactation and possible pregnancy
21)Participants already or possible participating in other clinical trials
22)Participants who are ineligible due to physician's judgment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo, The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2025 | Year | 04 | Month | 11 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065420
