UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055344 |
|---|---|
| Receipt number | R000063249 |
| Scientific Title | Investigation of the effects of Peucedanum japonicum root extract on lipid metabolism -Randomized, placebo-controlled, double-blind crossover study- |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/09/25 09:24:57 |
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Basic information
Public title
Investigation of the effects of Peucedanum japonicum root extract on lipid metabolism
-Randomized, placebo-controlled, double-blind crossover study-
Acronym
Investigation of the effects of Peucedanum japonicum root extract on lipid metabolism
Scientific Title
Investigation of the effects of Peucedanum japonicum root extract on lipid metabolism
-Randomized, placebo-controlled, double-blind crossover study-
Scientific Title:Acronym
Investigation of the effects of Peucedanum japonicum root extract on lipid metabolism
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the effects of Peucedanum japonicum root extract on lipid metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood lipids
Key secondary outcomes
Blood biochemistry tests
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of placebo food (4 weeks) -> Washout (2 weeks) -> Intake of active food (4 weeks)
Interventions/Control_2
Intake of active food (4 weeks) -> Washout (2 weeks) -> Intake of placebo food (4 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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1)Healthy Japanese males aged of 30-49 years
2)Participants whose BMI are 25.0 kg/m2=< and <30.0kg/m2
3)Participants whose body fat ratio are 20%=<
4)Participants who can visit on schedule days
5)Participants who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1)Participants who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs
2)Participants who have been diagnosed or taking medication with dyslipidemia, high blood pressure, or diabetes
3)Participants who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study
4)Participants who regularly use health foods and supplements affecting the study
5)Heavy drinker (over 40g alcohol/day)
6)Smokers
7)Participants who fasting triglycerides >=200 mg/dL at screening test
8)Participants who feel bad mood by blood collect
9)Participants 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
10)Late-night Shift worker
11)Participants who plan business trip or trip on average more than 10 days per month (excluding Obon vacation and New Year's holidays)
12)Participants who may have allergy symptoms to any of the ingredients contained in the test food or provided food
13)Participants who participated in other clinical studies in the past 3 months or who plan to participate in other clinical studies during the study period
14)Participants who are ineligible due to physician's judgement
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hoshino |
Organization
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name
General Medicine Clinical Departments: Internal Medicine Respiratory Medicine Allergy
Zip code
003-0011
Address
7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-868-2711
n-abe@medi-ate.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-shi, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
t-ashino@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
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
| 2025 | Year | 07 | Month | 01 | 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
10
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
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063249
