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

February 2, 2026 updated by: María Isabel Iguacel Azorín, Universidad de Zaragoza

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • Universidad of Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

- 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: Control
No intervention
Experimental: Anti-inflammatory diet
Other: Anti-inflammatory diet
We will use an anti-inflammatory diet to assess its impact on physical, mental and cognitive health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anxiety level (Depression, Anxiety, Stress Scale; DASS-42)
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
Depression level (Depression, Anxiety, Stress Scale; DASS-42)
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
SF-36
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
GLUCEMIC PROFILE
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
INFLAMMATORY PROFILE
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
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
From enrollment to the end of treatment at 16 weeks
Sleep quality (Pittsburg Sleep Quality Index)
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
Food Frequency Questionnaire
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
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
From enrollment to the end of treatment at 16 weeks
BMI
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
Weight
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
CD-RISK
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks
LIPID PROFILE
Time Frame: From enrollment to the end of treatment at 16 weeks
From enrollment to the end of treatment at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 16, 2026

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-inf-AI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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