UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007444
Receipt number 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 17:03:10

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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 or person

Institute

The University of Tokushima

Institute

Department

Personal name



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

Value
https://center6.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