UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023216 |
|---|---|
| Receipt number | R000026733 |
| Scientific Title | Continuing of functional foods intake for eating habits in elderly people |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2017/07/20 20:34:50 |
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Basic information
Public title
Continuing of functional foods intake for eating habits in elderly people
Acronym
Continuing of functional foods intake for eating habits in elderly people
Scientific Title
Continuing of functional foods intake for eating habits in elderly people
Scientific Title:Acronym
Continuing of functional foods intake for eating habits in elderly people
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the continuing of functional food intake for eating habit in elderly people who live in different hometown.
Basic objectives2
Others
Basic objectives -Others
To investigate the factors related to continuing of functional food intake for eating habit in elderly people who live in different home town.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating frequency of functional foods contaning inulin and calcium for 12 weeks.
Key secondary outcomes
Satisfaction for eating of functional foods contaning inulin and calcium for 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Piriods:90 days
Frequency of sample foods intake:Once a day.
The intake time and how to intake samples foods:For preference
Amount of intake:Five grams as inulin-fiber powder
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjecs who can eat sample food or meal by oral
Subjecs who can record preference for sample food or meal.
Subjecs who can reord the amount and frequency of defecation, who are self-sustaining at home.
Subjecs who are living welfare -nursing home and have the ability of agreement for participating to this study.
Key exclusion criteria
Subjecs who are under-severe control in their diet for diabetes and kidney disfunction desease with being diagnosed.
Subjecs who have recieved a follow-up examination from doctor by brain-vascular disease and alzheimer's disease.
Subjecs who have some troubles in food intake by oral.
Subjecs who can not have a normal meal and normal defication by digestive disease.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 Japan
TEL
04-2947-6778
mtaguchi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 Japan
TEL
04-2947-6778
Homepage URL
mtaguchi@waseda.jp
Sponsor or person
Institute
Waseda University, Faculty of Sport Sciences
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | 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
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 26 | 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
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2017 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026733
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
