UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006087 |
|---|---|
| Receipt number | R000007205 |
| Scientific Title | Evaluation of the efficacy and the safety of processed onion product on human muscle metabolism for the inpatient. |
| Date of disclosure of the study information | 2011/08/23 |
| Last modified on | 2016/04/03 16:23:57 |
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Basic information
Public title
Evaluation of the efficacy and the safety of processed onion product on human muscle metabolism for the inpatient.
Acronym
Clinical trial of intake of processed onion product for the inpatient.
Scientific Title
Evaluation of the efficacy and the safety of processed onion product on human muscle metabolism for the inpatient.
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Junji Terao |
Organization
The University of Tokushima
Division name
Department of Food Science, Institute of Health Biosciences, the University of Tokushima Graduate School
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Terao |
Organization
The University of Tokushima
Division name
Department of Food Science, Institute of Health Biosciences, the University of Tokushima Graduate Sc
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7087
Homepage URL
terao@nutr.med.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 23 | 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
| 2011 | Year | 07 | Month | 15 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
