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Enrolling by Invitation

NCT Number: NCT07398040

Clinical Impact of an Anti-Inflammatory Diet in Anxiety and Depression With AI

The goal of this clinical trial is to evaluate the effectiveness of an anti-inflammatory dietary intervention on physical health, mental health, and cognitive functioning in individuals with clinically diagnosed anxiety and/or depression, and to assess the agreement between artificial intelligence-based analysis of verbal and non-verbal language patterns and standard psychometric assessment tools.

The study will include adult participants (≥18 years) with a clinical diagnosis of anxiety and/or depressive disorder, irrespective of sex or gender.

The main questions it aims to answer are:

Does a 4-month anti-inflammatory dietary intervention improve mental health outcomes (anxiety and depressive symptoms) compared to a control condition in individuals with anxiety and/or depression?

Does the intervention lead to improvements in physical health and cognitive functioning relative to the control group?

Are verbal and non-verbal language patterns analyzed using artificial intelligence coherent with the results obtained from validated anxiety and depression questionnaires at baseline?

Do changes in AI-derived language markers parallel changes in clinical and self-reported outcomes following the dietary intervention?

Primary outcomes / hypotheses:

Does the anti-inflammatory dietary intervention produce greater reductions in anxiety and depressive symptom severity compared to the control group after 4 months?

Does the intervention result in significant improvements in physical health and cognitive performance compared to the control group?

Researchers will compare the anti-inflammatory diet intervention group with the control group (usual diet or standard dietary advice) to determine whether the intervention leads to superior improvements in mental, physical, and cognitive health outcomes.

Participants will:

Complete baseline assessments including validated questionnaires on anxiety, depression, physical health, cognitive functioning, and quality of life.

Undergo structured interviews at baseline during which verbal and non-verbal language data will be recorded and analyzed using artificial intelligence-based models.

Be allocated to either the anti-inflammatory dietary intervention group or the control group.

Follow their assigned dietary condition for 4 months.

Complete post-intervention assessments identical to baseline, including psychometric questionnaires and cognitive and physical health evaluations.

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Key information

Conditions

Depression - Major Depressive Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad of Zaragoza

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria: Age 18 years or older.

Presence of mild, moderate, or severe symptoms of anxiety, depression, or stress, as measured by the DASS-42 questionnaire.

Absence of medical contraindications to following a personalized diet.

Absence of cognitive impairment.

Proficiency in the Spanish language (ability to speak and understand fluently).

Availability over a 4-month period to attend scheduled assessments and intervention sessions.

Low or moderate adherence to the Mediterranean diet, as assessed by the Mediterranean Diet Adherence Questionnaire (score ≤ 9 out of 14).

Residence in the city of Zaragoza for the entire duration of the study.

Signed informed consent after receiving detailed information about the study.

  • Exclusion Criteria: DASS-42 scores compatible with either extremely severe symptomatology (requiring urgent clinical care) or with normal-range results.

Presence of organic pathologies that prevent adherence to the dietary intervention or that significantly interfere with the conduct of the study.

Inability to attend the scheduled in-person sessions.

Diagnosis or suspicion of a clinically unstable systemic medical disorder, or a physical illness currently causing severe physical and/or mental distress (e.g., an active flare of inflammatory bowel disease).

Pregnancy.

Current participation in another specific intervention focused on diet or exercise.

Diagnosis of severe psychiatric disorders, such as bipolar disorder type I or II, or a personality disorder as the primary clinical diagnosis.

Current substance use disorder.

Medical diagnosis that could explain or mask potential psychopathology, such as hormonal alterations (e.g., uncontrolled thyroid dysfunction).

Treatment and study plan

Anti-inflammatory diet

Other

We will use an anti-inflammatory diet to assess its impact on physical, mental and cognitive health

Control

Other

No intervention

Primary outcomes

  1. Anxiety level (Depression, Anxiety, Stress Scale; DASS-42)

    Time frame: From enrollment to the end of treatment at 16 weeks

  2. Depression level (Depression, Anxiety, Stress Scale; DASS-42)

    Time frame: From enrollment to the end of treatment at 16 weeks

  3. SF-36

    Time frame: From enrollment to the end of treatment at 16 weeks

  4. GLUCEMIC PROFILE

    Time frame: From enrollment to the end of treatment at 16 weeks

  5. INFLAMMATORY PROFILE

    Time frame: From enrollment to the end of treatment at 16 weeks

Secondary outcomes

  1. Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)

    Time frame: From enrollment to the end of treatment at 16 weeks

  2. Physical activity (International Physical Activity Questionnaire)

    Time frame: From enrollment to the end of treatment at 16 weeks

    We evaluate intense, moderate and soft physical activity through IPAQ questionnaire

  3. Sleep quality (Pittsburg Sleep Quality Index)

    Time frame: From enrollment to the end of treatment at 16 weeks

  4. Food Frequency Questionnaire

    Time frame: From enrollment to the end of treatment at 16 weeks

  5. Adherence to Mediterranean diet (MEDAS Scale)

    Time frame: From enrollment to the end of treatment at 16 weeks

    We evaluate the adherence to the mediterranean diet through MEDAS scale

  6. BMI

    Time frame: From enrollment to the end of treatment at 16 weeks

  7. Weight

    Time frame: From enrollment to the end of treatment at 16 weeks

  8. CD-RISK

    Time frame: From enrollment to the end of treatment at 16 weeks

  9. LIPID PROFILE

    Time frame: From enrollment to the end of treatment at 16 weeks

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

Clinical Impact of an Anti-Inflammatory Diet in Anxiety and Depression Detected by an AI-Based Screening Model

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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