UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033231 |
|---|---|
| Receipt number | R000037890 |
| Scientific Title | Evaluate a diet program that ingests carbohydrates and controls calories |
| Date of disclosure of the study information | 2018/07/03 |
| Last modified on | 2020/03/24 10:02:09 |
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Basic information
Public title
Evaluate a diet program that ingests carbohydrates and controls calories
Acronym
Evaluate a diet program that ingests carbohydrates and controls calories
Scientific Title
Evaluate a diet program that ingests carbohydrates and controls calories
Scientific Title:Acronym
Evaluate a diet program that ingests carbohydrates and controls calories
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to provide meals for 8 weeks and snacks and evaluate slimming effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight, body fat percentage, BMI, waist circumference, hip circumference
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Provide meals for 8 weeks and snacks and evaluate slimming effect
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Men and women over 20 years old
2.BMI 23 or more
Key exclusion criteria
1.Subjects receiving treatment for slimming purpose
2.Subjects during pregnancy, lactating
3.Subjects who participated in other clinical trials within one month, those planned to participate
4.Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Masatomo |
| Middle name | |
| Last name | Najima |
Organization
Japan clinical trial association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan clinical trial association
Institute
Department
Personal name
Funding Source
Organization
SONOKO 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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2018 | Year | 07 | Month | 03 | 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
| 2018 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037890
