UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024186 |
|---|---|
| Receipt number | R000027846 |
| Scientific Title | Dose-ranging study to evaluate efficacy of single administration of amino acid mixture combined with exercise on fat metabolism in overweight adults |
| Date of disclosure of the study information | 2016/09/27 |
| Last modified on | 2016/09/27 14:31:12 |
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Basic information
Public title
Dose-ranging study to evaluate efficacy of single administration of amino acid mixture combined with exercise on fat metabolism in overweight adults
Acronym
Dose-ranging study of amino acid mixture with single administration
Scientific Title
Dose-ranging study to evaluate efficacy of single administration of amino acid mixture combined with exercise on fat metabolism in overweight adults
Scientific Title:Acronym
Dose-ranging study of amino acid mixture with single administration
Region
| Japan |
Condition
Condition
Overweight
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and effective dose of amino acid mixture on fat metabolism during exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Blood ketone bodies level
Key secondary outcomes
Blood glycerol level
Blood free fatty acid level
Blood amino acids level
Blood triglyceride level
Blood glucose level
Blood lactic acid level
Blood adrenaline level
Blood noradrenaline level
Blood insulin level
Blood glucagon level
heart rate
beats per minute
questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Dose1-wash out-Dose2-wash out-Dose3-wash out-placebo
Interventions/Control_2
Dose2-wash out-placebo-wash out-Dose1-wash out-Dose3
Interventions/Control_3
Dose3-wash out-Dose1-wash out-placebo-wash out-Dose2
Interventions/Control_4
placebo-wash out-Dose3-wash out-Dose2-wash out-Dose1
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 65 years age and/or whose BMI of 25 to 30 kg/m^2
3) Men who has no regular exercise (more than two times a week/30 minutes or more in one year)
Key exclusion criteria
1) Sever systemic diseases
2) Subjects who drink a lot of alcohol
3) Smoker
4) Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker)
5) Constant use of oral medication or supplements affecting body fat
6) Subjects who donated blood within 3 months before starting of administration.
7) Phenylketonuria, and hyperphenylalaninemia
8) Subjects who has food allergy
9) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
16
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
Food Science Research Laboratories, 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
| 2016 | Year | 09 | Month | 27 | 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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 12 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2016 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027846
