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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024186
Receipt No. 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

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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
Email 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
Email m.i@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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