UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028144 |
|---|---|
| Receipt number | 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 20:00:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hmurata567@aoni.waseda.jp
Sponsor or person
Institute
Faculty of Sport Sciences, Waseda university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032093
