UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038268
Receipt number 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 16:39:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kagawa Nutrition University
Nutrition Clinid

Institute

Department

Personal name



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

Value
https://center6.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