UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dietary protein quality evaluation by indicator amino acid oxidation technique
Title of the study (Brief title)	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	Yasuhiro Kido
Organization	Kanazawa Gakuin University
Division name	Department of Health and Nutrition, Faculty of Human Health
Address	10, Suemachi, Kanazawa, Ishikawa
TEL	076-229-8782
Email	y-kido@kanazawa-gu.ac.jp

Public contact
Name of contact person	Yasuhiro Kido
Organization	Kanazawa Gakuin University
Division name	Department of Health and Nutrition, Faculty of Human Health
Address	10, Suemachi, Kanazawa, Ishikawa
TEL	076-229-8782
Homepage URL
Email	y-kido@kanazawa-gu.ac.jp

Sponsor
Institute	Department of Health and Nutrition, Faculty of Human Health,Kanazawa Gakuin University
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035897