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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005999
Receipt No. R000006899
Scientific Title Evaluation of the efficacy and the safety of soy protein on human muscle metabolism. -On the healthy subject.
Date of disclosure of the study information 2011/07/26
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.
-On the healthy subject.
Acronym Clinical trial of intake of soybean protein ingredients.
-On the healthy subject.
Scientific Title Evaluation of the efficacy and the safety of soy protein on human muscle metabolism.
-On the healthy subject.
Scientific Title:Acronym Clinical trial of intake of soybean protein ingredients.
-On the healthy subject.
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Not applicable Adult
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)Body weight, blood pressure, pulse rate
2) Hematology test and urine analysis
3)Adverse events
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 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
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)Subject must be aged =>20 years.
2)Both men and women
3)Subject who have no regular exercise (<1hour/1week)
4)Subject who consent to participate in this study in person.
Key exclusion criteria 1)Subject with disease under treatment(Diabetes, Chronic kidney disease)
2)Subject who have soybean allergy and milk allergy.
3)Subject who take the health food supplement including the soybean.
4)Pregnant female, lactating female
5)Subject who can't undergo MRI scan.
6)Subject who have been enrolled in this study within the last 2weeks.
7)Subject who refuse to participate in
this study.
8)Subject who is difficult to participate in this study in the opinion of the investigator.
Target sample size 16

Research contact person
Last 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
1st 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
Homepage URL
Email nikawa@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 Japan

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
2011 Year 07 Month 26 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 No longer recruiting
Date of protocol fixation
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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
2011 Year 07 Month 19 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=R000006899


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