UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031544 |
|---|---|
| Receipt number | R000035897 |
| Scientific Title | Dietary protein quality evaluation by indicator amino acid oxidation technique |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2019/02/05 15:29:27 |
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Basic information
Public title
Dietary protein quality evaluation by indicator amino acid oxidation technique
Acronym
Dietary protein quality evaluation
Scientific Title
Dietary protein quality evaluation by indicator amino acid oxidation technique
Scientific Title:Acronym
Dietary protein quality evaluation
Region
| Japan |
Condition
Condition
Healthy males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate two types of dietary milk protein requirement of adult men
Basic objectives2
Others
Basic objectives -Others
To evaluate the quality of dietary protein in humans using recently developed indicator amino acid oxidation method (IAAO method).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of carbon dioxide in expired gas
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Adult men ingest milk protein in the range of 0.4~1.4 g/kg BW/day
Interventions/Control_2
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
| Not applicable |
Gender
Male
Key inclusion criteria
20 or older male
Enegy intake over 30 kcal/kg BW/day
Protein intake over 0.6 g/kg BW/day
Key exclusion criteria
Milk-allergies
Subjects who are liable to loose stools by dairy intake ( a cup of mile or so)
Presence of chronic disease
Undergoing drug therapy or planning for drug therapy
Participation in another clinical study
Subjects who are assessed by the principal investigator to be unsuitable to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kido |
Organization
Kanazawa Gakuin University
Division name
Department of Health and Nutrition, Faculty of Human Health
Zip code
Address
10, Suemachi, Kanazawa, Ishikawa
TEL
076-229-8782
y-kido@kanazawa-gu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kido |
Organization
Kanazawa Gakuin University
Division name
Department of Health and Nutrition, Faculty of Human Health
Zip code
Address
10, Suemachi, Kanazawa, Ishikawa
TEL
076-229-8782
Homepage URL
y-kido@kanazawa-gu.ac.jp
Sponsor or person
Institute
Department of Health and Nutrition, Faculty of Human Health,Kanazawa Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
金沢学院大学人間健康学部健康栄養学科（石川県）
Department of Health and Nutrition, Faculty of Human Health,Kanazawa Gakuin University
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 03 | 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
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035897
