UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018161 |
|---|---|
| Receipt number | R000021024 |
| Scientific Title | Effect of fat metabolism by amino acids mixture during exercise on obesity men : a randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2015/07/03 |
| Last modified on | 2016/07/04 09:24:45 |
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Basic information
Public title
Effect of fat metabolism by amino acids mixture during exercise on obesity men : a randomized, double-blind, placebo-controlled study
Acronym
Effect of fat metabolism by amino acids mixture during exercise on obesity men
Scientific Title
Effect of fat metabolism by amino acids mixture during exercise on obesity men : a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
Effect of fat metabolism by amino acids mixture during exercise on obesity men
Region
| Japan |
Condition
Condition
No (Subjects whose BMI are 25 to 30)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the lipid metabolism effect by administration of amino acids mixture during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glycerol level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
Capsules containing 3 g of amino acids mixture, 1 per serving 1 trial
Interventions/Control_2
Capsules containing 3 g of dextrin, 1 per serving 1 trial
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
<1>Subjects giving written informed consent
<2>Men 30 to 50 years age
1) Men whose BMI of 25 to 30 and/or visceral fat area less than 200 cm 2.
2) Men who has no regular exercise (30 minutes or more / time more than three times a week)
Key exclusion criteria
<1>Sever systemic diseases
<2>Subjects who drink a lot of alcohol
<3>Smoker
<4>Subjects whose eating habits are extremely irregular.
<5>Midnight and irregular shift worker
<6>Constant use of oral medication or supplements affecting body fat and/or body
<7>Subjects who donated blood within 6 months before starting of administration.
<8>Phenylketonuria, and hyperphenylalaninemia
<9>Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
k.s@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
Homepage URL
m.i@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
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
| 2015 | 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
| 2015 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 05 | 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
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2016 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021024
