UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise training and functional food intake on physical function in the elderly - with special reference to the time of day
Title of the study (Brief title)	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	Yasuo Kawakami
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa city, Saitama
TEL	04-2947-6784
Email	ykawa@waseda.jp

Public contact
Name of contact person	Yasuo Kawakami
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa city, Saitama
TEL	04-2947-6784
Homepage URL
Email	ykawa@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030603