UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

katsura@eternal-esthetic.com

Name of contact person

1st name	Hirokuni
Middle name
Last name	Kayama

Organization

imeQ RD inc.

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL

Email

h-kayama@imeqrd.co.jp

Institute

imeQ RD inc.

Institute

Department

Personal name

Organization

Eternal Co.,Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

suda-clinic_irb@imeq.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

08

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

08

Month

11

Day

Last modified on

2020

Year

12

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047245