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NCT07398040
Clinical Impact of an Anti-Inflammatory Diet in Anxiety and Depression With AI
NA trial testing Anti-inflammatory diet in Depression - Major Depressive Disorder in 60 participants. Enrolling by invitation.
28 February 2026
Quick facts
| Lead sponsor | Universidad de Zaragoza |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 16 January 2026 |
| Primary completion | 28 February 2026 |
| Estimated completion | 30 September 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Anti-inflammatory diet
- Control
Conditions studied
- Depression - Major Depressive Disorder — all drugs for Depression - Major Depressive Disorder →
- Anxiety — all drugs for Anxiety →
Sponsor
Universidad de Zaragoza — full company profile →
Who can join
18 and older, any sex, with Depression - Major Depressive Disorder or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07398040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07398040 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de Zaragoza
- Last refreshed: 9 February 2026
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing