UMIN-CTR Clinical Trial

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
Email	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
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036521