UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051633 |
|---|---|
| Receipt number | R000058894 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group comparative study on the effect of continuous intake of the test food on visceral fat in healthy adult men and women |
| Date of disclosure of the study information | 2023/07/23 |
| Last modified on | 2023/07/18 15:10:52 |
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Basic information
Public title
Verification of the effects of continuous intake of the test food on visceral fa
Acronym
Verification of the effects of continuous intake of the test food on visceral fat
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group comparative study on the effect of continuous intake of the test food on visceral fat in healthy adult men and women
Scientific Title:Acronym
A randomized, double-blind, placebo-controlled, parallel-group comparative study on the effect of continuous intake of the test food on visceral fat in healthy adult men and women
Region
| Japan |
Condition
Condition
healthy adult men and women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of test food intake on visceral fat area.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat area
Key secondary outcomes
Weight, BMI, waist circumference, hip circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test food for 12 weeks
Interventions/Control_2
Continuous intake of control food for 12 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged between 20 and 60 at the time of obtaining written consent
2) Persons with a BMI of 23 or more and less than 30
3) Subjects who have received a sufficient explanation of the purpose and content of the research, are capable of giving consent, have fully understood the study, voluntarily applied to participate in the study, and agreed to participate in the study in writing.
Key exclusion criteria
1.show severe allergy to the test food
2.with an implantable defibrillator such as a pacemaker
3.have a current or a history of skin diseases,
4.develop severe allergy to metals
5.with severe anemia
6.Currently pregnant or breastfeeding. Or a person who may have such a possibility during the test period
7.Liver/kidney/cardiac disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, brain disease, malignant tumor, immune disease, serious disease such as heart disease, thyroid disease, other metabolic diseases Those who have a serious current disease such as disease or a history
8.are currently undergoing drug treatment, outpatient treatment, diet therapy, or exercise therapy for any serious or chronic disease.
9.are aware of dysmenorrhea or PMS symptoms
10.using health foods, supplements, and medicines that affect test results
11.with current or past drug or alcohol dependence
12.are undergoing hospital visits due to mental disorders (depression, etc.), sleep disorders, etc., or have a history of mental disorders in the past
13.with irregular life rhythm due to night work or shift work
14.lifestyle habits may change during the period from the preliminary examination
15.with extremely irregular lifestyles such as eating and sleeping
16.have an extremely unbalanced diet
17.participated in other clinical trials (research) within 3 months prior to the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period
18.have collected or donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining informed consent
19.have difficulty keeping track of various questionnaires
20.judged to be unsuitable as subjects based on clinical test values and measured values at the time of SCR
21.are judged to be inappropriate as subjects by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
BHN Co., Ltd
Division name
EBF Business Promotion Office
Zip code
101-0054
Address
1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo,, Japan
TEL
03-5281-5661
d-ochitani@bhn.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
BHN Co., Ltd
Division name
EBF Business Promotion Office
Zip code
101-0054
Address
1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-5281-5661
Homepage URL
d-ochitani@bhn.co.jp
Sponsor or person
Institute
BHN Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Jinmon 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2023 | Year | 07 | Month | 23 | 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
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058894
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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