UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026649
Receipt number R000030603
Scientific Title Effects of exercise training and functional food intake on physical function in the elderly - with special reference to the time of day
Date of disclosure of the study information 2017/03/22
Last modified on 2017/10/02 09:48:28

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Basic information

Public title

Effects of exercise training and functional food intake on physical function in the elderly - with special reference to the time of day

Acronym

Effects of exercise training and functional food intake on physical function in the elderly - with special reference to the time of day

Scientific Title

Effects of exercise training and functional food intake on physical function in the elderly - with special reference to the time of day

Scientific Title:Acronym

Effects of exercise training and functional food intake on physical function in the elderly - with special reference to the time of day

Region

Japan


Condition

Condition

Healthy elderly people

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effects of exercise training and functional food intake on physical and cognitive functions in the elderly

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Walking abilities

Key secondary outcomes

1)Body composition
2)Morphology
3)Skeletal muscle thickness
4)Subcutaneous adipose tissue thickness
5)Skeletal muscle mass
6)Visceral fat
7)Muscular strength
8)Dynamic balance abilities
9)Static balance abilities
10)Cognitive functions


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Exercise training and intake of functional food A and placebo food for 3 months

Interventions/Control_2

Exercise training and intake of functional food A and functional food B for 3 months

Interventions/Control_3

Intake of functional food A and placebo food for 3 months

Interventions/Control_4

Exercise training and intake of placebo food A and placebo food B for 3 months

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit

89 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy male and female elderly adults with no restriction of physical activity

Key exclusion criteria

1)Individuals being prohibited from exercising by a doctor
2)Individuals with recent incidents of heart attack and/or stroke(within the last 6 months)
3)Individuals with acute hepatic insufficiency and/or chronic viral hepatitis
4)Individuals with diabetes and an incident of hypoglycemic attack
5)Individuals with decreased cognitive function due to cerebrovascular disease and Alzheimer's disease
6)Individuals with heart disease and the use of pacemakers
7)Individuals with acute orthopedic pain and neurological symptom
8)Individuals with osteoporosis and compression fracture
9)Individuals with other diseases which prevent them from participating in regular exercise
10)Individuals with allergies to dairy product, egg, wheat, soybean, pork, chicken, fish meat, gelatin and olive
11)Individuals with kidney disorder
12)Individuals with implanted metallic materials(pacemakers, artificial joint, etc.)
13)Individuals with claustrophobia

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Kawakami

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima, Tokorozawa city, Saitama

TEL

04-2947-6784

Email

ykawa@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Kawakami

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima, Tokorozawa city, Saitama

TEL

04-2947-6784

Homepage URL


Email

ykawa@waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Cubinet office, Government of Japan, Cross-ministerial Strategic Innovation Promotion Program

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2017 Year 03 Month 22 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

2017 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 20 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

2017 Year 03 Month 22 Day

Last modified on

2017 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030603


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name