UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032189
Receipt number R000036715
Scientific Title Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people
Date of disclosure of the study information 2018/04/11
Last modified on 2019/04/11 10:26:35

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Basic information

Public title

Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people

Acronym

Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people

Scientific Title

Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people

Scientific Title:Acronym

Effects of exercise and milk protein drink ingestion on muscle mass and strength in elderly people

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of 6 months ingestion of milk protein drink following exercise on muscle mass and strength in people aged 60 or more compared to placebo drink.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Isokinetic muscle strength (knee extension and flexion)

Key secondary outcomes

Grip strength, push up, walking speed, timed "Up & Go" test, sit-to-stand test, functional reach, body weight, lean body mass, fat mass, segmental lean mass, muscle thickness, blood analysis, executive function, blood pressure, pulse rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

6 months ingestion of milk protein drink (68 kcal, 10.1 g protein, 7.0 g carbohydrate, 0.2 g fat/day) and exercise

Interventions/Control_2

6 months ingestion of placebo drink (68 kcal, 0.1 g protein, 16.0 g carbohydrate, 0.5 g fat/day) and exercise

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Able to provide written consent and understand the study requirements and procedures
2) Age 60 or more

Key exclusion criteria

1) Significant kidney, liver, respiratory, cardiovascular or digestive disease
2) Significant orthopedic injury
3) Milk or soy allergies
4) Significant abnormal value of blood pressure or pulse rate
5) Significant abnormal value of blood test
6) Protein restriction
7) Resistance training (3 days/week or more and 30 min/day or more)
8) Not submit first dietary records
9) Participate in other study
10) Judged as unsuitable for this study by the doctor for other reasons

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadasu Urashima

Organization

Obihiro University of Agriculture & Veterinary Medicine

Division name

Graduate School of Food Hygiene

Zip code


Address

Nishi2sen 11banchi, Inada cho, Obihiro, Hokkaido 080-8555, Japan

TEL

+81-155-49-5577

Email

urashima@obihiro.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chiaki Sanbongi

Organization

Meiji Co., Ltd.

Division name

Food Science & Technology Research Laboratories

Zip code


Address

1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan

TEL

+81-42-632-5846

Homepage URL


Email

chiaki.sanbongi@meiji.com


Sponsor or person

Institute

Obihiro University of Agriculture & Veterinary Medicine

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Edihas Co., Ltd.

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

帯広畜産大学


Other administrative information

Date of disclosure of the study information

2018 Year 04 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


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

Completed

Date of protocol fixation

2018 Year 02 Month 09 Day

Date of IRB

2018 Year 02 Month 09 Day

Anticipated trial start date

2018 Year 05 Month 09 Day

Last follow-up date

2018 Year 11 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 10 Day

Last modified on

2019 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036715


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name