UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023421
Receipt No. R000026988
Scientific Title The effect of odor training on olfactory function of elderly people.
Date of disclosure of the study information 2016/08/02
Last modified on 2017/08/02

* 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 effect of odor training on olfactory function of elderly people.
Acronym The effect of odor training on olfactory function of elderly people.
Scientific Title The effect of odor training on olfactory function of elderly people.
Scientific Title:Acronym The effect of odor training on olfactory 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 food odor training for 12 weeks on olfactory 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 Results of Open Essence Test and Food Odor Identification Test(before and after 12-week training)
Key secondary outcomes Questionnaire Survey (Related to olfactory function)

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 not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Elderly people are asked to sniff five representative food odors for 10 seconds by twice a day during 12 weeks (methods reported by Hummel, 2009).
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy elderly subjects in Nangoku city who provide written informed consent.
Key exclusion criteria 1)Subjects who regularly visit otorhinolaryngology.
2)Subjects without enough recognition ability to do olfactory training.
3)Subjects who cannot open training vials.
4)Subjects who have allergy of salmon.
5)Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumino Okutani
Organization Kochi Medical School
Division name Department of Occupational Health
Zip code
Address Nankoku, Kochi 783-8505
TEL 088-880-2560
Email okutanif@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Okabe
Organization Ajinomoto Co., Inc
Division name Human health & nutrition group, Institute of food sciences & technologies
Zip code
Address 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi
TEL 044-223-4114
Homepage URL
Email yuki_okabe@ajinomoto.com

Sponsor
Institute Kochi Medical School
Institute
Department

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
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 08 Month 02 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 08 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 21 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 08 Month 01 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026988

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.