UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029242 |
|---|---|
| Receipt number | R000033423 |
| Scientific Title | The effect of intake of Peucedanum japonicum on vasceral fat. |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2018/04/18 12:00:51 |
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Basic information
Public title
The effect of intake of Peucedanum japonicum on vasceral fat.
Acronym
The effect of intake of Peucedanum japonicum on vasceral fat.
Scientific Title
The effect of intake of Peucedanum japonicum on vasceral fat.
Scientific Title:Acronym
The effect of intake of Peucedanum japonicum on vasceral fat.
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine changes in visceral fat of subjects who take Peucedanum japonicum for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of abdominal visceral fat area by CT examination.
(Before intake, after intake 4weeks, after intake 8weeks and after intake 12weeks.)
Key secondary outcomes
Biochemical indicator, Body composition
(Before intake, after intake 4weeks, after intake 8weeks and after intake 12weeks.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects takes the 12-week test food. The evaluation is carried out every four weeks.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women from 20 years old to 80 years old
2. Those who fully understand and document agreed by free will of the subject person was obtained after having received a sufficient explanation of the study
3. BMI >=25kg/m2, <30kg/m2
4. Visceral fat area >=80cm2
Key exclusion criteria
1. Taking drugs that may affect obesity, hyperlipidemia or lipid metabolism
2. Taking sapplement or functional foods that may affect obesity, hyperlipidemia or lipid metabolism
3. Those who are routinely regular use "Peucedanum japonicum"
4. Embedding metal in the abdomen
5. Severe hepatic disorder, kidney / heart disease, organ disorder, diabetes, other serious diseases
6. It is diagnosed as familial hyperlipidemia
7. Have a history of food allergy
8. More than 500 ml of beer per day (25 ml in terms of alcohol)
9. There are more than 20 smokers on average per day
10. During pregnancy, pregnancy, and also during pregnancy wishing for pregnancy
11. Participating in other clinical trials or planning to participate
12. Other, who investigators were ineligible
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ohno |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2, Yamadaoka, Suita, OSAKA
TEL
06-6879-3498
ohno@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Sakaue |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2, Yamadaoka, Suita, OSAKA
TEL
06-6879-3498
Homepage URL
mikity@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Okinawa TLO Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 10 | Month | 20 | 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
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 22 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033423
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
