UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020929 |
|---|---|
| Receipt number | R000024148 |
| Scientific Title | Effect of the anti-obesity mixture in metabolic-syndrome : a randomized controlled trial |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2016/02/08 12:56:53 |
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Basic information
Public title
Effect of the anti-obesity mixture in metabolic-syndrome : a randomized controlled trial
Acronym
Effect of the anti-obesity mixture in metabolic-syndrome :
Scientific Title
Effect of the anti-obesity mixture in metabolic-syndrome : a randomized controlled trial
Scientific Title:Acronym
Effect of the anti-obesity mixture in metabolic-syndrome :
Region
| Japan |
Condition
Condition
Metabolic-syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assume the effect of the anti-obesity mixture in metabolic-syndrome :
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF8
Body fat
Fasting blood sugar level
Triglyceride, T-Cho,LDL-Cho,HDL-Cho,TG
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
Control food
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20<=age<70
Male and female
Out patients
25<=BMI<=30
Healthy adults
Nonsmoker
Those who are able to obtained consent document
Key exclusion criteria
Patient with severe disease
Those who cannot avoid drinking the day before study.
Those who were participating in other clinical trials within one month
Those who may suffer the risk.
Those who may not provide enough data.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Megumi Hayakawa |
Organization
GMC Ltd.
Division name
CEO
Zip code
Address
108-3 Higashi-matsumoto Gosho-City Nara, Japan
TEL
0744-47-4395
info@gmc-earth.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Hayakawa |
Organization
GMC Ltd.
Division name
CEO
Zip code
Address
108-3 Higashi-matsumoto Gosho-City Nara, Japan
TEL
0744-47-4395
Homepage URL
info@gmc-earth.com
Sponsor or person
Institute
GMC Ltd.
Institute
Department
Personal name
Funding Source
Organization
GMC 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
Address
Tel
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
| 2016 | Year | 02 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2016 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024148
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
