UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018522 |
|---|---|
| Receipt number | 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 10:11:42 |
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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
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
y1kawano@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021438
