UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044322 |
|---|---|
| Receipt number | R000050625 |
| Scientific Title | Influence on physical condition by "healthy meal" intake on obese males |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2021/11/24 09:02:57 |
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Basic information
Public title
Influence on physical condition by "healthy meal" intake on obese males
Acronym
Influence on physical condition by "healthy meal" intake on obese males
Scientific Title
Influence on physical condition by "healthy meal" intake on obese males
Scientific Title:Acronym
Influence on physical condition by "healthy meal" intake on obese males
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change on physical condition by "healthy meal" intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat area
Key secondary outcomes
BMI, blood triglyceride level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake "healthy meal B" for 20 days
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Males aged between 30 and 64
2) Subjects who equal to or more than 23 kg/m2 of BMI
3) Among the subjects who met the inclusion criteria 1) and 2), select from the subjects with high visceral fat area
Key exclusion criteria
1) Subjects who are unable to continuously intake "healthy meal" during intake period
2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and the results of preliminary examination
3) Subjects who are judged as unsuitable for the study based on the medical history
4) Subjects with food allergies
5) Subjects who have difficulty in treatment by participating in the study
6) Subjects who are receiving treatment or use equipment that affects the examination
7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
8) Subjects who have participated in other clinical study prior to the current study
9) Subjects who routinely take health foods that may affect the results
10) Subjects who has a history of disease that may affect the results
11) Subjects who has a habit of skipping breakfast
12) Subjects who regularly consume large amount of alcohol
13) Subjects who smoke excessively (more than 21 cigarettes a day)
14) Subjects with extremely irregular diet
15) Subjects with irregular life rhythms
16) Subjects who undergoes a medical examination from 2 weeks before the preliminary examination and the end of the study
17) Subjects who plan to donate blood during the study period
18) Subjects who judged as unsuitable for the study by the investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Mizuyama |
Organization
Medical Foundation Doujinkinenkai Meiwa Hospital
Division name
Internal medicine
Zip code
101-0041
Address
1-18, Kanda Sudacho, Chiyoda-ku, Tokyo
TEL
03-3251-0263
mizuyama@crux.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Turuya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
shimada767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
non-disclosure
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
saito876@eps.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
| 2021 | Year | 05 | Month | 25 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050625
