An interventional study of Anti-inflammatory diet and Control in Depression - Major Depressive Disorder and Anxiety, sponsored by Universidad de Zaragoza. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Universidad de Zaragoza is the lead sponsor of 111 studies on the registry; 18 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
- 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 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 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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Anti-inflammatory diet
Other: Control
We will use an anti-inflammatory diet to assess its impact on physical, mental and cognitive health
No intervention
Anxiety level (Depression, Anxiety, Stress Scale; DASS-42)
Time frame: 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
SF-36
Time frame: From enrollment to the end of treatment at 16 weeks
GLUCEMIC PROFILE
Time frame: From enrollment to the end of treatment at 16 weeks
INFLAMMATORY PROFILE
Time frame: From enrollment to the end of treatment at 16 weeks
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Time frame: From enrollment to the end of treatment at 16 weeks
Physical activity (International Physical Activity Questionnaire)
We evaluate intense, moderate and soft physical activity through IPAQ questionnaire
Time frame: 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
Food Frequency Questionnaire
Time frame: From enrollment to the end of treatment at 16 weeks
Adherence to Mediterranean diet (MEDAS Scale)
We evaluate the adherence to the mediterranean diet through MEDAS scale
Time frame: From enrollment to the end of treatment at 16 weeks
BMI
Time frame: From enrollment to the end of treatment at 16 weeks
Weight
Time frame: From enrollment to the end of treatment at 16 weeks
CD-RISK
Time frame: From enrollment to the end of treatment at 16 weeks
LIPID PROFILE
Time frame: From enrollment to the end of treatment at 16 weeks
Plan to share: No
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