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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007444
Receipt No. R000008774
Scientific Title Evaluation of the efficacy and the safety of soy protein on human muscle metabolism 3.On the healthy subject
Date of disclosure of the study information 2012/03/27
Last modified on 2012/03/05

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Basic information
Public title Evaluation of the efficacy and the safety of soy protein on human muscle metabolism
3.On the healthy subject
Acronym Clinical trial of intake of soybean protein ingredients
3.On the healthy subject
Scientific Title Evaluation of the efficacy and the safety of soy protein on human muscle metabolism
3.On the healthy subject
Scientific Title:Acronym Clinical trial of intake of soybean protein ingredients
3.On the healthy subject
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and the efficacy of soybean protein ingredients on muscle atrophy.
On the healthy subject.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Volume of large hamstring muscles
2)Marker of muscle athropy(3Met-His,
CK)
3)Marker of oxidative stress(8-OHdG)
4)Muscle strength
5)Ubiquitination of muscle protein
6)Expression of genes involved in muscle atrophy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) 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 Soybean protein ingredient
Interventions/Control_2 Powdered cazein(Milk)
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)Subject must be aged>20 years.
2)Both men and women
3)Subject who consent to participate in this study in person.
Key exclusion criteria 1)Chronic kidney disease
2)Neural and muscle disease
3)History of breast cancer
4)Subject who have soybean allergy and milk allergy.
5)Subject who take the health food supplement including the soybean.
6)Pregnant female, lactating female
7)History of allergy to local anesthetics such as lidocaine.
8)Subject who can't undergo MRI scan.
9)Subject who have been enrolled in this study within the last 2weeks.
10)The case that subject refuse 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 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nikawa
Organization The University of Tokushima
Division name Graduate School of Nutrition and Bioscience -Nutritional Physiology
Zip code
Address 3-18-15Kuramoto-cho, Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nikawa
Organization The University of Tokushima
Division name Graduate School of Nutrition and Bioscience -Nutritional Physiology
Zip code
Address 3-18-15Kuramoto-cho, Tokushima
TEL 088-633-9247
Homepage URL
Email nikawa@nutr.med.tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima
Institute
Department

Funding Source
Organization 1)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
Email

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
2012 Year 03 Month 27 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 Preinitiation
Date of protocol fixation
2012 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 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
2012 Year 03 Month 05 Day
Last modified on
2012 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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