UMIN-ICDS Clinical Trial

Public title

A study of how patients with eating disorders perceive foods

Acronym

Food Perception Study

Scientific Title

A comparative study of subjective value assessment of food tasks in outpatients with anorexia nervosa and avoidant/restrictive food intake disorder

Scientific Title:Acronym

Outpatient AN/ARFID Food Image Task Study

Region

Japan

Condition

Anorexia nervosa; Avoidant/restrictive food intake disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to compare subjective value ratings and subjective nutritional ratings obtained using a 90-item food image task between outpatients with anorexia nervosa and those with avoidant/restrictive food intake disorder. Associations with eating disorder symptoms, subjective state changes before and after the task, autistic traits, ADHD symptoms, clinical severity, and physical indices will also be explored.

Basic objectives2

Others

Basic objectives -Others

Comparison of subjective value ratings and subjective nutritional ratings using a food image task

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Subjective value ratings in the food image task, including wanting to eat, perceived healthiness, and perceived tastiness on an 8-point scale, and subjective nutritional ratings, including perceived calories, carbohydrates, fat, and protein on a 7-point scale. These outcomes will be assessed once after informed consent.

Key secondary outcomes

Eating Disorder Inventory scores, Numerical Rating Scale scores before and after the food image task for anxiety, disgust, and unwillingness to eat and their changes, AQ-J scores at first visit, ASRS scores at first visit, CGI-S at study participation, illness duration, and diagnoses at first visit and study participation.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

11

years-old

<=

Age-upper limit

50

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Outpatients at the Department of Psychiatry and Neurology, Yamaguchi University Hospital, who are diagnosed with anorexia nervosa or avoidant/restrictive food intake disorder according to the DSM-5 criteria
2) Aged 11 to 50 years at the time of written informed consent
3) Individuals who have received sufficient explanation of the purpose and procedures of the study and have provided written informed consent
4) For minors, written consent from a legally acceptable representative and assent from the participant are required
5) No restriction on sex

Key exclusion criteria

1) Comorbid schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, or depressive disorders according to the DSM-5
2) Suspected intellectual disability with an IQ below 70 and substantial difficulty understanding or completing the study tasks
3) Neurological disorders that may affect brain function, including epilepsy, cerebrovascular disease, sequelae of head injury, or neurodegenerative disease
4) Severe physical comorbidities, including hepatic dysfunction with AST or ALT greater than 100 IU/L or renal dysfunction with serum creatinine greater than 2.0 mg/dL
5) Continuous use of high doses of medications that may substantially affect cognitive function or responsiveness
6) Individuals considered unsuitable for participation by the principal investigator or a study investigator

Target sample size

40

Name of lead principal investigator

1st name	Fumihiro
Middle name
Last name	Higuchi

Organization

Yamaguchi University Hospital

Division name

Division of Neuropsychiatry

Zip code

7558505

Address

1-1-1 Minamikogushi, Ube, Yamaguchi

TEL

0836222255

Email

seisin@yamaguchi-u.ac.jp

Name of contact person

1st name	Fumihiro
Middle name
Last name	Higuchi

Organization

Yamaguchi University Hospital

Division name

Division of Neuropsychiatry

Zip code

7558505

Address

1-1-1 Minamikogushi, Ube, Yamaguchi

TEL

0836222255

Homepage URL

Email

seisin@yamaguchi-u.ac.jp

Institute

Department of NeuroPsychiatry, Yamaguchi University Hospital

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee, Yamaguchi University Hospital

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

Tel

0836-22-2428

Email

me223@yamaguchi-u.ac.jp

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

07

Month

28

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

2026

Year

07

Month

13

Day

Date of IRB

2026

Year

07

Month

28

Day

Anticipated trial start date

2026

Year

07

Month

29

Day

Last follow-up date

2028

Year

06

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center prospective observational study of outpatients with anorexia nervosa (AN) or avoidant/restrictive food intake disorder (ARFID).
Participants will be classified into the AN or ARFID group according to their diagnosis at study participation. Subjective value ratings (wanting to eat, perceived healthiness, and perceived tastiness) and subjective nutritional ratings (perceived calories, carbohydrates, fat, and protein) will be assessed using a 90-item food image task and compared between the two diagnostic groups. Associations with clinical variables, including EDI scores, pre- and post-task NRS scores, AQ-J scores, ASRS scores, CGI-S, illness duration, BMI, and percentage of standard body weight, will also be explored.
Eligible patients attending the outpatient clinic of the Department of Psychiatry and Neurology, Yamaguchi University Hospital, during the recruitment period will be enrolled after written informed consent is obtained from the participant or a legally acceptable representative. No random sampling, group assignment, or therapeutic intervention will be performed as part of the study. The target sample size is 40 participants: 20 with AN and 20 with ARFID.
Participant recruitment will begin after registration and public disclosure in the UMIN-CTR and will continue until March 31, 2028.

Registered date

2026

Year

07

Month

28

Day

Last modified on

2026

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071383