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
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
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
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
