UMIN-CTR Clinical Trial

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

Community-dwelling elderly people

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

KSO Corporation

Institute

Department

Personal name

Organization

AJINOMOTO CO., INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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