UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041388 |
|---|---|
| Receipt number | R000047245 |
| Scientific Title | Study to evaluate the effect of continuous use of the test product on muscle mass and body fat |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2024/05/16 15:45:54 |
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Basic information
Public title
Study to evaluate the effect of continuous use of the test product on muscle mass and body fat
Acronym
Study to evaluate the effect of continuous use of the test product on muscle mass and body fat
Scientific Title
Study to evaluate the effect of continuous use of the test product on muscle mass and body fat
Scientific Title:Acronym
Study to evaluate the effect of continuous use of the test product on muscle mass and body fat
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on muscle mass and body fat by continuous use of the test product in healthy men and women between the ages of 30 and 60 years old.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area, subcutaneous fat area, total fat area, and muscle mass
Key secondary outcomes
Physical examination (weight, BMI, waist circumference), body fat percentage, basal metabolic rate, and leptin.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use the test product once a week for 30 minutes.
Interventions/Control_2
Do not use the test product.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 30 to 60 years old (at the time of submission of an informed consent document).
2. Japanese male and female.
3. BMI of over 25 to under 30
4. Those who can input the electronic diary by smart phone or PC.
5. Those who can obtain written consent.
Key exclusion criteria
1. Those who are currently undergoing treatment with some kind of medicine or Chinese herbal medicine (abortive use is acceptable.)
2. Those who have serious liver, kidney, heart, respiratory, endocrine or metabolic diseases.
3. Those who have history of treatment for heart failure, myocardial infarction, etc.
4.Those who are taking diet and exercise therapy under the supervision of a doctor.
5. Those who have a cardiac pacemaker or an implantable medical device placed in the body.
6. Those who have metal in their body due to surgery.
7. Those who have a history of complications of seizure disorders such as epilepsy.
8. Those who have sensory impairment.
9. Those who had a gastrointestinal operation (appendicitis is acceptable.)
10. Those who are taking health food (foods or supplements that affect body composition, or are intended to maintain or restore health).
11. Those who cannot refrain from taking other health foods during the study period.
12. Those who are allergic to drugs or food allergies, and have a current or former illness.
13. Those who consume excessive amounts of alcohol(more than 60g alcohol equivalent/day).
14. Pregnant, lactating, or wanting to become pregnant during the study period.
15. Those who are participating in another clinical trial within one month.
16. Those who were judged to be unsuitable for participation in this study by study investigators or sub-investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Katsura |
Organization
Eternal Co.,Ltd.
Division name
Planning & Strategy Dept.
Zip code
541-0056
Address
1-9-5 Kyutaromachi Chuo-ku Osaka City Osaka Japa
TEL
090-8570-0882
katsura@eternal-esthetic.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Eternal Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2020 | Year | 08 | Month | 14 | 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
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047245
