UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018587
Receipt number R000021444
Scientific Title The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.
Date of disclosure of the study information 2015/08/07
Last modified on 2015/08/06 19:00:51

* 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

The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.

Acronym

The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.

Scientific Title

The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.

Scientific Title:Acronym

The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.

Region

Japan


Condition

Condition

sarcopenia

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of peptide ingestion in addition to strength training on the muscle strength and muscle mass of middle-aged and elderly people for whom the maintenance of muscle is important to prevent sarcopenia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle mass

Key secondary outcomes

muscle strength, IGF-1, and IL-6


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

placebo food

Interventions/Control_2

test food

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Participants in Jukunen Taiikudaigaku Project in Matsumoto
2) Over 40 years old

Key exclusion criteria

1) Subjects who were subject to the restriction of exercise within 3 month.
2) Subjects who are subject to the restriction of protein ingestion due to kidney disorder etc.
3) Subjects who ingest foods fortified with protein, peptide or amino acid regularly.
4) Subjects who have milk allergy.
5) Subjects who have a history of sever disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
6) Subject who are judged inappropriate to this study by the investigator.

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Oh Tae-Woong

Organization

Matsumoto University

Division name

Health Science

Zip code


Address

2095-1, Niimura, Matsumoto-shi, Nagano, JAPAN

TEL

0263-48-7351

Email

ohtw-72@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Oh Tae-Woong

Organization

Matsumoto University

Division name

Health Science

Zip code


Address

2095-1, Niimura, Matsumoto-shi, Nagano, JAPAN

TEL

0263-48-7351

Homepage URL


Email

ohtw-72@umin.ac.jp


Sponsor or person

Institute

Matsumoto University

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industry Co., Ltd.

Organization

Division

Category of Funding Organization

Profit 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

2015 Year 08 Month 07 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

2015 Year 07 Month 16 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 08 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

2015 Year 08 Month 07 Day

Last modified on

2015 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021444


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name