UMIN-ICDS Clinical Trial

Public title

The effects of flavor differences in food on the mind

Acronym

The effects of food on mind

Scientific Title

A randomized, double-blind, crossover study on the effects of flavor differences in food on emotional and physiological indices

Scientific Title:Acronym

A randomized, double-blind, crossover study on the effects of different food flavors on emotional and physiological indices

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A randomized, double-blind, crossover study will be conducted in healthy subjects to examine the effects of a single intake of the test food on emotional and physiological indicators.

Basic objectives2

Others

Basic objectives -Others

Confirm changes in mood associated with food consumption and corresponding changes in physiological indicators

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Subjective evaluation (VAS;Degree of "feel at ease")

Key secondary outcomes

(1) Frontal EEG
(2) Earlobe plethysmography
(3) Subjective evaluations (Paired comparison test,VAS;Other emotions and preferences)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

A single intake of the test food (4g) in Phase I. After a washout period of at least one day, a single intake of the control food (4g) in Phase II. After another washout period of at least one day, in Phase III, a single intake of the practice food (4g) or the corresponding the sample (4g) if there was an issue during measurement in either Phase I or II. Subsequently, for paired comparison test, a single intake of the test food(4g) followed by a single intake of the control food (4g).

Interventions/Control_2

A single intake of the control food (4g) in Phase I. After a washout period of at least one day, a single intake of the test food (4g) in Phase II. After another washout period of at least one day, in Phase III, a single intake of the practice food (4g) or the corresponding the sample (4g) if there was an issue during measurement in either Phase I or II. Subsequently, for paired comparison test,a single intake of the control food(4g) followed by a single intake of the test food (4g).

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

20

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Adult men and women aged 20 to 69 at the time of consent
(2) Those who don't dislike milk chocolate
(3) Those who self-report healthy
(4) Those who have received sufficient information about the purpose and content of this study, are competent to consent, can fully understand the content, and can give their own consent through electromagnetic informed consent.

Key exclusion criteria

(1)Those who currently receiving medical treatment or medication from a doctor for any disease (chronic diseases such as diabetes or high blood pressure, digestive diseases such as gastrectomy, gastric ulcers or reflux esophagitis, malignant tumors, kidney disease, heart disease, etc.)
(2)Those who currently taking or using any medication, including prescription or over-the-counter medications (excluding emergency medications)
(3)Those who with taste disorders, hay fever or rhinitis symptoms
(4)Those who are using medication for runny nose or nasal congestion
(5)Those who using pacemakers
(6)Those who with chronic oral diseases or symptoms
(7)Those who undergoing dental treatment or wearing orthodontic appliances that may affect the evaluation
(8)Those who are allergic to dairy or soy ingredients
(9)Those who regularly use foods for specified health uses, functional foods, health foods, etc. that affect the autonomic nervous system
(10)Those who have experienced a life event such as moving, changing jobs, or separation from a close relative within the three months prior to obtaining consent and may be under significant stress, or subjects who are scheduled to experience a similar life event during the study period.
(11)Those who are planning to travel or go on a business trip of 7 days or more between October 2025 and March 13, 2026, or who may go on a business trip or travel
(12)Those who Regular alcohol users: Generally, more than 60g of alcohol per day
(13)Those who with extremely irregular sleeping or eating habits
(14)Those who are currently participating in another clinical trial, or have participated within the past four weeks of obtaining consent, or those who plan to participate in another clinical trial during the study period
(15)Women who are breastfeeding, pregnant, possibly pregnant, or intend to become pregnant during the study period
(16)Other subjects who are judged by the investigator to be ineligible to be subjects

Target sample size

40

Name of lead principal investigator

1st name	Soma
Middle name
Last name	Ode

Organization

Macromill, Inc.

Division name

Clinical Trial Department, Life Science Division

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

03-6716-0700

Email

ohde@macromill.com

Name of contact person

1st name	Aya
Middle name
Last name	Takahashi

Organization

Macromill, Inc.

Division name

Clinical Trial Department, Life Science Division

Zip code

108-0075

Address

Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan

TEL

03-6716-0700

Homepage URL

Email

ay_takahashi@macromill.com

Institute

Macromill, Inc.

Institute

Department

Personal name

Organization

LOTTE CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Review Committee of Watanabe Hospital

Address

1-5-16 Haneda, Ota-ku, Tokyo, Japan

Tel

03-3741-0223

Email

wnb.cto@gmail.com

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

2026

Year

01

Month

15

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

Preinitiation

Date of protocol fixation

2025

Year

12

Month

24

Day

Date of IRB

2025

Year

12

Month

24

Day

Anticipated trial start date

2026

Year

01

Month

16

Day

Last follow-up date

2026

Year

03

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

01

Month

15

Day

Last modified on

2026

Year

01

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069031