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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028144
Receipt No. R000032093
Scientific Title The effcet by the intake of functional food on healthy status in female elder people
Date of disclosure of the study information 2017/07/08
Last modified on 2018/06/13

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Basic information
Public title The effcet by the intake of functional food on healthy status in female elder people
Acronym The effcet by the intake of functional food
Scientific Title The effcet by the intake of functional food on healthy status in female elder people
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuru Higuchi
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
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
1st name
Middle name
Last name Hiroko Murata
Organization Waseda University
Division name Organization for University Research Initiatives (Higuchi laboratory)
Zip code
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)

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 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

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 06 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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