AzTrials
AzTrials

ARFIDDNA_ARFIDNCT07478510

Cognitive Evaluation of Patients With Eating Disorders

An observational study of ARFID and Anorexia Nervosa, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this cross - sectional observational study is to improve understanding of the psychological and cognitive characteristics of Feeding and Eating Disorders (FEDs), a group of conditions that represent a growing public health concern due to their significant impact on physical health, emotional well-being… Read more about this study

Who is it for?
Ages 14 to 65 yearsHealthy volunteers can take part
Conditions the study is for
ARFID, Anorexia Nervosa, Bulimia Nervosa
What is being tested?
Go/No-go, IAT and WCST
How many people
84 participants
Where
3 sitesItaly
Study dates
26 Nov 2024to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study population includes adolescent and adult participants aged between 14 and 65 years, of both sexes, recruited among individuals diagnosed with Feeding and Eating Disorders and healthy control volunteers. The clinical group consists of patients with a diagnosis of Avoidant/Restrictive Food Intake Disorder, anorexia nervosa, or bulimia nervosa, with a Body Mass Index (BMI) lower than 25. Eligible participants must meet the diagnostic criteria for a Feeding and Eating Disorder according to DSM-5-TR and must provide written informed consent to participate in the study. For participants under the age of 18, written consent from parents or legal guardians is required in addition to the minor's assent. A group of healthy control participants will be recruited in order to obtain a sample balanced with the patient group in terms of sex, age, and educational level. The same inclusion and exclusion criteria applied to the patient group will be considered for the control group.

Who may be able to join

  • Diagnosis of a Feeding and Eating Disorder (ARFID, anorexia nervosa, or bulimia nervosa);
  • Patients of both sexes;
  • Age between 14 and 65 years;
  • Confirmed diagnosis of a Feeding and Eating Disorder;
  • Body Mass Index (BMI) < 25;
  • Signed informed consent form for participation in the study.

Who cannot join

  • Diagnosis of Bipolar Disorder according to DSM-5-TR criteria;
  • Diagnosis of a Schizophrenia Spectrum Disorder according to DSM-5-TR criteria;
  • Intellectual disability according to DSM-5-TR criteria;
  • Presence of brain tumors;
  • History of seizure events;
  • Presence of other moderate to severe neurological disorders;
  • Lack of the patient's consent to voluntary participation in the study;
  • Lack of parental or legal guardian consent for participation of a minor in the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Giulia Mattavelli, Associated prof., researcher contact

+39 3397893500

giulia.mattavelli@iusspavia.it

Italy3 sites, 3 recruiting
  • Istituto Psicologico Italiano s.r.l.s.

    Milan, 20124

    Pablo Zuglian, PhD, 349 7430677, pablo.zuglian@istitutopsicologico.it

    Recruiting
  • ASST Fatebenefratelli Sacco

    Milan, 20157

    Lorenzo Casati, MD Psychiatrist, +390239042904, lorenzo.casati@asst-fbf-sacco.it

    Recruiting
  • IUSS Pavia - Istituto Universitario di Studi Superiori

    Pavia, PV, 27100

    Giulia Camilla Mattavelli, giulia.mattavelli@iusspavia.it

    Recruiting

Other trials in Italy

About this study

Official title: Neuro-cognitive Profiles of Patients With Nutritional and Eating Disorders

The goal of this cross - sectional observational study is to improve understanding of the psychological and cognitive characteristics of Feeding and Eating Disorders (FEDs), a group of conditions that represent a growing public health concern due to their significant impact on physical health, emotional well-being, and everyday functioning. Within this broader diagnostic category, particular attention is given to Avoidant/Restrictive Food Intake Disorder (ARFID), a diagnosis introduced in the DSM-5 and still relatively underexplored compared to other feeding and eating disorders.

Despite its clinical relevance, ARFID remains less well understood in terms of its underlying cognitive and psychological mechanisms. Individuals with ARFID often experience severe food avoidance or restriction that is not driven by weight or shape concerns, but rather by sensory sensitivities, fear of negative consequences of eating, or a lack of interest in food. For this reason, investigating ARFID can offer important insights into the diversity of mechanisms involved in feeding and eating disorders as a whole.

Read more

The study has two main objectives. The first objective is to examine the cognitive profile of individuals with ARFID, with a specific focus on autistic traits and cognitive flexibility, as previous research suggests potential overlaps between ARFID and neurodevelopmental conditions such as Autism Spectrum Disorders. Cognitive flexibility refers to the ability to adapt thoughts and behaviors in response to changing situations, and reduced flexibility may contribute to rigid eating patterns and food avoidance.

The second objective is to explore the role of body representation (how individuals perceive and mentally represent their own body) and inhibitory control (the ability to regulate or suppress automatic responses) in shaping the cognitive and behavioral features of ARFID and other feeding and eating disorders. These processes may help distinguish ARFID from other diagnoses and clarify shared and disorder-specific mechanisms across the FED spectrum.

The study involves adult participants of all genders, including individuals diagnosed with ARFID, anorexia nervosa, and bulimia nervosa, as well as healthy control participants without a history of feeding or eating disorders. This design allows meaningful comparisons between different diagnostic groups and with the general population.

The main questions the study aims to answer are:

Do individuals with ARFID show a distinct cognitive profile, particularly in terms of autistic traits and cognitive flexibility, compared to individuals with other feeding and eating disorders and healthy controls?

How do body representation and inhibitory control contribute to differences in eating-related behaviors across feeding and eating disorders?

Are there differences in brain activity associated with implicit, automatic attitudes toward food in individuals with feeding and eating disorders compared to healthy individuals?

Where comparison groups are included, researchers will compare participants with ARFID, anorexia nervosa, bulimia nervosa, and healthy controls to examine differences in cognitive functioning, psychological characteristics, and neural responses related to food processing.

Participants will be asked to take part in a series of non-invasive and well-established research activities, designed to be accessible and safe. These include:

Completing self-report questionnaires assessing autistic traits, body image perception, and general psychological well-being;

Performing computer-based tasks that assess cognitive flexibility and decision-making;

Completing behavioral tasks designed to measure inhibitory control and automatic associations with food-related stimuli;

Being tested
Go/No-go, IAT, WCST
Medical subject headings
Avoidant Restrictive Food Intake Disorder, Anorexia Nervosa, Bulimia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Go/No-goBehavioural

    The investigators designed a specific task, base in literature, to evaluate the inibithory response to food stimuli of different types (high calories, low calories, neutral stimuli). The images have been defined by a pilot selection and added to the task designed on Psychopy.

  • IATBehavioural

    The investigators designed a specific task, base in literature, to evaluate the implicit association of body images (overweight, underweight, normalweight) and word to different lables. The body images have been defined by a pilot selection and added to the task designed on Psychopy.

  • WCSTBehavioural

    The Wisconsin Card Sorting Test (WCST) is a neuropsychological assessment of executive function, cognitive flexibility, and abstract reasoning. Participants match stimulus cards based on color, form, or number, adapting to changing, unstated rules based on examiner feedback. It measures the ability to display flexibility in the face of changing schedules of reinforcement, specifically "set-shifting". A participant is given a deck of cards and told to match them, but not how. The examiner says "right" or "wrong," forcing the participant to deduce the rule (color, shape, or number). The rule changes unexpectedly after a certain number of correct matches. It provides scores for categories completed, trials, total errors, and, critically, perseverative errors (continuing to use a previous, invalid rule). The investigators used the 128 cards version.

Study groups in NCT07478510
Study groupRoleWhat they receive
Healthy controlEvery participant recieve all the interventions described, each one of them with the specific randomization of subministration.
Receives: Behavioral: Go/No-go; Behavioral: IAT; Behavioral: WCST
ARFIDPatients with Avoidant Restrictive Food Intake Disorder. Every participant recieve all the interventions described, each one of them with the specific randomization of subministration.
Receives: Behavioral: Go/No-go; Behavioral: IAT; Behavioral: WCST
AN/BNPatients with a diagnosis of Anorexia Nervosa or Bulimia Nervosa. Every participant recieve all the interventions described, each one of them with the specific randomization of subministration.
Receives: Behavioral: Go/No-go; Behavioral: IAT; Behavioral: WCST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility?

    The Autism Spectrum Quotient (AQ) questionnarie has the purpose to evaluate the levels of autistic traits in each participant and permit to understand the differences between the groups.

    The scoring of this questionnaire stays in the range 0-50, where 0 is the minimum and associated with less autistic traits and 50 is the maximum outcome possible, explaining elevated autistic traits. Usually, the cut-off is defined as 32, over that score is possible to define the presence of autistic traits.

    Measured: Baseline

  2. What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility?

    The higher the percentage of perseverative errors out of the total errors made on the Wisconsin Card Sorting Test (WCST), the lower the subject's cognitive flexibility. The WCST assesses executive functions, particularly cognitive flexibility, set-shifting ability, and problem-solving strategies. Scoring is typically based on several indices, including number of categories completed, total errors, and perseverative errors, with perseverative errors often expressed as a percentage of total responses.

    There is no universally accepted clinical cut-off for WCST performance, as interpretation is usually based on comparison with age-adjusted normative data; however, higher percentages of perseverative errors are generally interpreted as indicating greater executive dysfunction.

    The scale starts at 0%, which indicates full cognitive flexibility, and increases accordingly torwards 100%, indicating cognitive rigidity.

    Measured: Baseline

Secondary outcomes (4)
  1. What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa?

    The assessment of body representation is carried out through the scoring and comparison of participants' scores through the scoring of the Implicit Association Task (IAT), involving implicit associations with body images. Scores on the D-scores emerging as outcomes from the computerized IAT task will be evaluated. The interpretation of scoring has this pattern:

    1. +0.15 <: no implicit preference
    2. 0.16 - 0.35: weak preference
    3. 0.36 - 0.65: moderate preference
    4. > 0.65: strong preference

    The theoretical range of D score is between -2 and 2, but in empirical practise it's moreover between -1,5 and 1,5.

    Measured: Baseline

  2. What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa?

    The assessment of body representation is carried out through the scoring and comparison of participants' scores on one of the questionnaires included in the project, namely the Body Image Concern Inventory (BICI). It is a 19-item self-report questionnaire assessing dysmorphic concerns related to body image. Each item is rated on a 5-point Likert scale (1 = never, 5 = always). The total score is obtained by summing all items and ranges from 19 to 95, with higher scores indicating greater body image concern. A commonly used cut-off is ≥55 (95th percentile in normative samples), suggesting clinically relevant dysmorphic concern. The scale also includes two subscales: F1 - Dysmorphic Symptoms (preoccupation with perceived appearance flaws) and F2 - Symptom Interference (impact of these concerns on daily functioning).

    Measured: Baseline

  3. What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa?

    The evaluation of inhibitory control capacity is carried out through a Go/No-go task. The test consists of high and low calorie food pictures or neutral stimuli (circles and squares). This kind of task presents two main outcomes: reaction time (RT) and accuracy.

    Reaction time is recorded in milliseconds (ms) and has no theoretical maximum, but in this specific protocol the range of evaluations of answers is between 300 and 1000 ms, where stimuli under 300ms reflects a pattern of impulsivity and stimuli over 1000 ms of answers are not registred by the task, defining low reactivity.

    Accuracy represents the percentage of correct responses (0-100%). The task does not have validated clinical cut-offs, as it is a continuous experimental measure rather than a diagnostic test. Normative interpretation is usually based on sample comparison or statistical ranges (e.g., mean ± 2 SD) rather than fixed thresholds.

    Measured: Baseline

  4. What is the role of body representation and inhibitory control capacity in the differential diagnosis between ARFID and other eating disorders, such as Anorexia Nervosa and Bulimia Nervosa?

    The Eating Disorder Inventory-3 (EDI-3) is a self-report questionnaire used to assess psychological and behavioral traits associated with eating disorders and is commonly used in the differential diagnosis, particularly to evaluate body image disturbance. It includes 91 items rated on a 6-point Likert scale that are recoded from 0 to 4 and summed to produce 12 primary scales.

    The instrument does not provide a single total score and cut-offs are not strictly diagnostic, although T-scores ≥60-65 are generally considered clinically elevated and ≥70 indicates high clinical concern.

    Scales most relevant for research on body representation and differential diagnosis are Drive for Thinness, Body Dissatisfaction, and Bulimia, which form the Eating Disorder Risk Composite. Individuals with ARFID are expected to show low scores on these body-image related dimensions compared to those with Anorexia Nervosa or Bulimia Nervosa.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start26 Nov 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07478510
Sponsor's protocol ID
0025652/24
Acronym
DNA_ARFID
Status last verified
Apr 2026
First submitted
2 Feb 2026
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of ARFID and Anorexia Nervosa, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giulia Mattavelli, Associated prof., researcher (+39 3397893500, giulia.mattavelli@iusspavia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

What is the cognitive profile of patients with ARFID, with particular reference to autistic traits and cognitive flexibility? (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in