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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038268
Receipt No. R000041810
Scientific Title Preliminary examination of the influence on muscle by the dry sake yeast GPS23 strain component food at the time of the BCAA intake
Date of disclosure of the study information 2019/10/11
Last modified on 2019/10/10

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Basic information
Public title Preliminary examination of the influence on muscle by the dry sake yeast GPS23 strain component food at the time of the BCAA intake
Acronym Preliminary examination of the influence on muscle by the dry sake yeast GPS23 strain component food at the time of the BCAA intake
Scientific Title Preliminary examination of the influence on muscle by the dry sake yeast GPS23 strain component food at the time of the BCAA intake
Scientific Title:Acronym Preliminary examination of the influence on muscle by the dry sake yeast GPS23 strain component food at the time of the BCAA intake
Region
Japan

Condition
Condition healthy adlut
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The muscles are known to increase by taking the BCAA. It is thought that it is more effectivery eating with polyamines.Therefore, We observe a chang of quqntity of muscle when we took in polyamine espcially spermidine rich dry yeast GSP23 with two kinds of capacity and placebos with BCAA.We inspect it in before and after for eight weeks during the intake period
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the quantity of lean body mass.
Key secondary outcomes prealbmin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 1group. 10 subjects intake the dry yeast GSP23 300mg and BCAA 1008mg/day in 8 weeks and cheak the blood test and measure their lean body mass at the base line and end the test.
Interventions/Control_2 2group.10 subjects intake the dry yeast GSP23 900mg and BCAA 1008mg/day in 8 weeks and cheak the blood test and measure their lean body mass at the base line and end the test.
Interventions/Control_3 3group.10 subjects intake the placebos and BCAA 1008mg/day in 8 weeks and cheak the blood test and measure their lean body mass at the base line and end the test.
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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male
Key inclusion criteria The normal man who does not receive treatment of the disease 50 years or older.
Person less than 30 more than BMI18.5.
The person that supplement within one month before examination start.
Key exclusion criteria A person treating mental diseases such as a serious disease.
The person who is thought about of allergy for the test food.
Person with allergy for the alcohol.
Person with impaired bone fracture, exercise function including rheumatism.
The person who a meal and the change of the momentum are big, and cannot maintain an everyday lifestyle constantly.
Person of the shift work, person with the graveyard shift.
Person who takes in natto more than twice a week.
The person who participates in other clinical trials within the past one month.
In addition, the person who judged that an examination responsibility doctor was inadequate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Tanaka
Organization Kagawa Nutrition University
Division name Nutrition Clinic
Zip code 170-8481
Address 3-24-3 Komagome,Tosima-ku,Tokyo,Japan
TEL 03-3918-6181
Email clinic@eiyo.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Kamachi
Organization Kagawa Nutrition University
Division name Nutrition Clinic
Zip code 170-8481
Address 3-24-3 Komagome,Tosima-ku,Tokyo.Japan
TEL 03-3918-6181
Homepage URL
Email Kamachi@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Nutrition Clinid
Institute
Department

Funding Source
Organization MITSUBISHI GAS CHEMICAL COMPANY, INC.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagawa Nutrition University
Address 3-21-9 Chiyoda,Sakado,Saitama,Japan
Tel 049-283-2131
Email clinic@eiyo.ac.jp

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 女子栄養大学 栄養クリニック

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 11 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 26
Results
when we eat  BCAA and the dry sake yeast 'GPS23' component food, it seems to increase their muscles.
Results date posted
2019 Year 10 Month 10 Day
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
2019 Year 04 Month 11 Day
Date of IRB
2019 Year 04 Month 18 Day
Anticipated trial start date
2019 Year 04 Month 11 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 10 Day
Last modified on
2019 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041810

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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