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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023216
Receipt No. 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

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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
Email 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
Email mtaguchi@waseda.jp

Sponsor
Institute Waseda University, Faculty of Sport Sciences
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026733

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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