UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032059 |
|---|---|
| Receipt number | R000036521 |
| Scientific Title | The effect of olfactory training using flavor enhanced food on cognitive function of elderly people. |
| Date of disclosure of the study information | 2018/04/21 |
| Last modified on | 2019/11/08 10:45:11 |
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Basic information
Public title
The effect of olfactory training using flavor enhanced food on cognitive function of elderly people.
Acronym
The effect of olfactory training using flavor enhanced food on cognitive function of elderly people.
Scientific Title
The effect of olfactory training using flavor enhanced food on cognitive function of elderly people.
Scientific Title:Acronym
The effect of olfactory training using flavor enhanced food on cognitive function of elderly people.
Region
| Japan |
Condition
Condition
Community-dwelling elderly people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of olfactory training using flavor enhanced food for 12 weeks on olfactory and cognitive function of elderly people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function
[1]Word fluency test, [2]TMT-A,B
([1]~[2] Before and after 12-week ingestion)
Key secondary outcomes
*Secondary outcomes
[1]WHO-5, [2]Olfactory identification test, [3]Questionnaire about diet and mood
([1]~[3] Before and 12-week ingestion)
*Safety
[1]Doctor's questions
[2]Body weight (BMI)
[3]Blood pressure and pulse rate
[4]Blood test, blood biochemical test, and urine analysis
([1]~[3] Before and after 12-week ingestion, [4]Screening and after 12-week ingestion)
*Other indexes
[1]Doctor's questions
[2]Body height and weight (BMI)
[3]Blood pressure and pulse rate
[4]Blood test, blood biochemical test, and urine analysis
[5]MMSE test
[6]Subject's diary
([1]~[5]Screening, [6]During 12-week ingestion)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Interventions group: Elderly people are asked to intake flavor enhanced food (test food), sniffing with a conscious awareness of the flavor. They are asked to repeat this training once a day during 12 weeks.
Interventions/Control_2
Control group: No treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[1]Males and females aged more than 65 years.
[2]Individuals whose written informed consent has been obtained.
Key exclusion criteria
[1]Individuals who have a history of mental or cerebrovascular diseases.
[2]Individuals who use medicines which may affect central nerve.
[3]Individuals who regularly visit otorhinolaryngology.
[4]Individuals who regularly intake supplements or healthy foods which may affect cognitive function.
[5]Individuals who regularly intake medicines for pollen allergy.
[6]Individuals whose score of MMSE test at screening are below 26.
[7]Individuals who have allergy of milk, wheat or dried bonito flakes.
[8]Individuals judged inappropriate by blood test at screening.
[9]Individuals who have a history of drug or alcohol dependence.
[10]Individuals who participate or will participate clinical studies.
[11]Individuals judged inappropriate for the trial by the principal.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Mine |
Organization
AJINOMOTO CO., INC.
Division name
Human Health & Nutrition Group, Institute of Food Sciences and Technologies
Zip code
Address
1-1, Suzuki-cho, Kawasaki-ku, kawasaki-shi 210-8681, Japan
TEL
044-223-4114
tomoyuki_mine@ajinomoto.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshika Komori |
Organization
KSO Corporation
Division name
Chairman & CEO
Zip code
Address
7F, Shibaura-Omodaka Bldg., 1-9-7, Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., INC.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 04 | Month | 21 | 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
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036521
