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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027502
Receipt No. R000031522
Scientific Title Effects of phenylalanine on energy expenditure and lipid oxidation during exercise
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/26

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Basic information
Public title Effects of phenylalanine on energy expenditure and lipid oxidation during exercise
Acronym Effects of phenylalanine on energy expenditure during exercise
Scientific Title Effects of phenylalanine on energy expenditure and lipid oxidation during exercise
Scientific Title:Acronym Effects of phenylalanine on energy expenditure during exercise
Region
Japan

Condition
Condition No
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of phenylalanine on energy expenditure and lipid oxidation during exercise
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Blood glycerol level
Key secondary outcomes Blood free fatty acid level
Blood glucose level
Blood glucagon level
Blood ketone bodies level
Respiratory exchange ratio

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 YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 placebo intake-wash out-Active sumple intake
Interventions/Control_2 Active sumple intake-wash out-placebo intake
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
39 years-old >
Gender Male
Key inclusion criteria Subjects giving written informed consent
Healthy men whose age 20 to 39 years old
Key exclusion criteria Sever systemic diseases
anemia
Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Fujita
Organization Ritsumeikan University
Division name College of Sport and Health Science
Zip code
Address 1-1-1, Nojihigashi, Kusatsu-shi, Shiga
TEL 077-561-5229
Email safujita@fc.ritsumei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Ueda
Organization Meiji Co.,Ltd.
Division name Food Science Research Laboratories
Zip code
Address 540, Naruda, Odawara, Kanagawa
TEL 0465-37-3796
Homepage URL
Email keisuke.ueda@meiji.com

Sponsor
Institute Ritsumeikan University
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Food Science Research Laboratories
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2017 Year 06 Month 01 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
2011 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 04 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
2017 Year 05 Month 26 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031522

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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