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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018522
Receipt No. R000021438
Scientific Title Effect of high protein intakes on post-absorptive energy metabolism
Date of disclosure of the study information 2015/09/01
Last modified on 2016/08/01

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Basic information
Public title Effect of high protein intakes on post-absorptive energy metabolism
Acronym Effect of high protein intakes on post-absorptive energy metabolism
Scientific Title Effect of high protein intakes on post-absorptive energy metabolism
Scientific Title:Acronym Effect of high protein intakes on post-absorptive energy metabolism
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to explore the relationship between protein intakes and postabsorptive energy thermogenesis
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diet induced thermogenesis (postabsorptive energy expenditure) is estimated using oxygen and carbon dioxide concentration in the expiration gas for 4 hours after the test breakfast was offered.
Key secondary outcomes Blood glucose, appetite, autonomic nervous activity, uric nitrogen

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 On an experimental day, high protein breakfast (30% energy ratio) was offered.
At least 3 days wash out.
On the second experimental day, low protein breakfast(10% energy ratio) was offered.
Interventions/Control_2 On an experimental day, low protein breakfast (10% energy ratio) was offered.
At least 3days wash out.
On the second experimental day, high protein breakfast (30% energy ratio) was offered.
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
18 years-old <=
Age-upper limit
25 years-old >
Gender Male and Female
Key inclusion criteria Healthy men assessed by perceived, clinical and biochemical parameters.
Key exclusion criteria 1) The person under medication and medical treatment
2) The person who are defined as lean or obese
3) The person who habitually perform intense physical activities
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari KAWANO
Organization Tokyo University of Agriculture
Division name Department of Nutritional Sciences
Zip code
Address Sakuraoka1-1-1, Setagaya, Tokyo
TEL 03-5477-2453
Email y1kawano@nodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukari KAWANO
Organization Tokyo University of Agriculture
Division name Department of Nutritional Sciences
Zip code
Address Sakuraoka1-1-1, Setagaya, Tokyo
TEL 03-5477-2453
Homepage URL
Email y1kawano@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization Tokyo University of Agriculture
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 東京農業大学栄養科学科(東京都)
Department of Nutritional Sciences, Tokyo University of Agriculture

Other administrative information
Date of disclosure of the study information
2015 Year 09 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
2015 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 11 Month 01 Day
Date analysis concluded
2017 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 02 Day
Last modified on
2016 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021438

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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