UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effcet by the intake of functional food on healthy status in female elder people
Title of the study (Brief title)	The effcet by the intake of functional food
Region	Japan

Condition
Condition	Osteiporosis, Locomotive syndrome, Metabolic syndrome
Classification by specialty	Cardiology Endocrinology and Metabolism Geriatrics Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of the intake of functional foods and exercise for physical characteristics, physical function, biological rythm and cognitive function in elderly people by randamized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Bone mineral density and biochemical marker of bone turnover (at baseline and after 12weeks intervention)
Key secondary outcomes	Physical functional parameter(muscle strength, muscle power, walking ability), ability of activity in daily living(questionaire), physical activity, time and pattern of excercise(accelometer), morningness-eveningness type(questionaire), risk factors of related lifestyle disease(glucose metabolism, lipid metabolism, liver function, bone metabolism, index of stress and inflammation, resistance for oxidative stress), blood miRNA profile, intestinal enviroment status(microbiological flora and composition of organic acid), depressive status (questionaire) at baseline and after 12wks intervention

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	YES
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Behavior,custom
Interventions/Control_1	The subjects of intervention group-1 without exercise habit at baseline have the intervention of intakes of the functional food containing 5-gram inulin and 200-miligram calcium per day and exercise intervention(a laboratory exercise using rowing ergometer for ten minutes per week in laboratory and home exercises using gum tube for ten minutes twice per week.
Interventions/Control_2	The subjects of intervention group-2 without exercise habit at baseline have the intervention of intakes of the functional food containing 5-gram resistant digestion dextrin and 200-miligram calcium per day and exercise intervention(a laboratory exercise using rowing ergometer for ten minutes per week in laboratory and home exercises using gum tube for ten minutes twice per week.
Interventions/Control_3	The subjects of intervention group-3 with exercise habit at baseline have the intervention of intakes of the functional food containing 5-gram inulin and 200-miligram calcium per day.
Interventions/Control_4	The subjects of intervention group-4 with exercise habit at baseline have the intervention of intakes of the functional food containing 5-gram resistant digestion dextrin and 200-miligram calcium per day.
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	79 years-old >=
Gender	Female
Key inclusion criteria	Healthy elderly female peopole with or without exercise habit at baseline and having ability of ability for agreement to this study
Key exclusion criteria	1. History or presence of diabetes, heart disease, liver disease and kidney disease, stroke, osteoporosis and alzheimer disease. 2. Physician has placed a restriction on physical exercise.
Target sample size	60

Research contact person
Name of lead principal investigator	Mitsuru Higuchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL	+81-4-2947-6745
Email	mhiguchi@waseda.jp

Public contact
Name of contact person	Hiroko Murata
Organization	Waseda University
Division name	Organization for University Research Initiatives (Higuchi laboratory)
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL	04-2947-6883
Homepage URL
Email	hmurata567@aoni.waseda.jp

Sponsor
Institute	Faculty of Sport Sciences, Waseda university
Institute
Department

Funding Source
Organization	Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program
Organization
Division
Category of Funding Organization	Other
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	早稲田大学スポーツ科学学術院（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 07 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 07 Month 08 Day
Last modified on	2018 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032093