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

NCT07398040 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Depression - Major Depressive Disorder
  • Anxiety

Interventions

OTHER

Anti-inflammatory diet

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

OTHER

Control

No intervention

Sponsors & Collaborators

  • Universidad de Zaragoza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2026-02-28
Completion
2026-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398040 on ClinicalTrials.gov