UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056681 |
|---|---|
| Receipt number | R000064761 |
| Scientific Title | A Study on the Effect of Test Substance P on Body Fat Reduction -Open Study- |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/01/08 09:18:16 |
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Basic information
Public title
A Study on the Effect of Test Substance P on Body Fat Reduction -Open Study-
Acronym
A Study on the Effect of Test Substance P on Body Fat Reduction
Scientific Title
A Study on the Effect of Test Substance P on Body Fat Reduction -Open Study-
Scientific Title:Acronym
A Study on the Effect of Test Substance P on Body Fat Reduction
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of test substance P on body fat
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight(BMI), and body fat percentage(mass) after 12 weeks
Key secondary outcomes
Other indexes related to body composition after 12 weeks
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
12-week intervention of test substance P
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 20 to 64 years-old.
(2)Subjects whose BMI are 18.5 or over and under 30.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
(1) have a chronic disease and use medications affecting obesity, muscle, glucose and lipid metabolism.
(2)contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disorders, blood circulation disorders, and/or metabolic disease, diseases of the locomotive organs).
(3)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity during test periods.
(4)have physical activity affected, or undergoing or scheduled to undergo treatment for locomotive organs.
(5)are not constitutionally suited to the test substance P.
(6)can't stop drinking from 2 days before each measurement.
(7)are judged as unsuitable for the current study by the investigator ased on the interview and vitals conducted during the screening test.
(8)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week.
(9)are under treatment for or have a history of drug addiction and/or alcoholism.
(10)are shift worker, midnight-shift worker, and/or subjects with extremely irregular dietary or exercise habits.
(11)are pregnant or planning to become pregnant or breastfeed during the study period.
(12)are participating in or willing to participate in other clinical studies using other foods, drugs, health appliances, or the application of cosmetics.
(13)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
40
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 | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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 Joto-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 | 01 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064761
