UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy and the safety of processed onion product on human muscle metabolism for the inpatient.
Title of the study (Brief title)	Clinical trial of intake of processed onion product for the inpatient.
Region	Japan

Condition
Condition	Inpatient
Classification by specialty	Neurology Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and the efficacy of processed onion product on muscle atrophy for the inpatient.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Sectional area of large hamstring muscles 2)Biomarker of muscle atrophy 3)Biomarker of oxidative stress 4)Muscle strength
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Processed onion product
Interventions/Control_2	Placebo powder
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)The inpatient 2)Subject with Performance Status(PS)2 or 3 3)Subject must be aged >= 20 years. 4)Both men and women 5)Subject who consents to participate in this study in each patient or legal representatives.
Key exclusion criteria	1)Primary muscle disease 2)Chronic kidney disease 3)Diabetic nephropathy(Stage3) 4)Subject who uses any medication of the muscle. 5)Subject who causes ill health by the intake of the onion and the welsh onion . 6)Subject who takes the health food supplement including many vegetable extracts. 7)Pregnant female, lactating female 8)Subject who can't undergo MRI scan. 9)Subject who has been enrolled in this study within the last 2weeks. 10)The case that subject refuses to participate in this study. 11)The case that it is difficult to participate in this study in the opinion of the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Junji Terao
Organization	The University of Tokushima
Division name	Department of Food Science, Institute of Health Biosciences, the University of Tokushima Graduate School
Address	3-18-15 Kuramoto-cho, Tokushima
TEL
Email

Public contact
Name of contact person	Junji Terao
Organization	The University of Tokushima
Division name	Department of Food Science, Institute of Health Biosciences, the University of Tokushima Graduate Sc
Address	3-18-15 Kuramoto-cho, Tokushima
TEL	088-633-7087
Homepage URL
Email	terao@nutr.med.tokushima-u.ac.jp

Sponsor
Institute	The University of Tokushima
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National Agriculture and Food Research Organization
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 15 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 01 Day
Last modified on	2016 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000007205