Depression - Major Depressive DisorderNCT07398040
Clinical Impact of an Anti-Inflammatory Diet in Anxiety and Depression With AI
A study testing Anti-inflammatory diet in people with Depression - Major Depressive Disorder and Anxiety, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety
- What is being tested?
- Anti-inflammatory diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Anti-inflammatory diet, Control
- Keywords
- Depression, Anxiety, Anti-inflammatory diet, Artificial Intelligence
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory dietOther
We will use an anti-inflammatory diet to assess its impact on physical, mental and cognitive health
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory diet | Experimental | Not described Receives: Other: Anti-inflammatory diet |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level (Depression, Anxiety, Stress Scale; DASS-42)
Measured: From enrollment to the end of treatment at 16 weeks
Depression level (Depression, Anxiety, Stress Scale; DASS-42)
Measured: From enrollment to the end of treatment at 16 weeks
SF-36
Measured: From enrollment to the end of treatment at 16 weeks
GLUCEMIC PROFILE
Measured: From enrollment to the end of treatment at 16 weeks
INFLAMMATORY PROFILE
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (9)
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Measured: 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
Measured: From enrollment to the end of treatment at 16 weeks
Sleep quality (Pittsburg Sleep Quality Index)
Measured: From enrollment to the end of treatment at 16 weeks
Food Frequency Questionnaire
Measured: 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
Measured: From enrollment to the end of treatment at 16 weeks
BMI
Measured: From enrollment to the end of treatment at 16 weeks
Weight
Measured: From enrollment to the end of treatment at 16 weeks
CD-RISK
Measured: From enrollment to the end of treatment at 16 weeks
LIPID PROFILE
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start16 Jan 2026 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Isabel Iguacel Azorín, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398040
- Sponsor's protocol ID
- Anti-inf-AI
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of an Anti-Inflammatory Diet in Anxiety and Depression Detected by an AI-Based Screening Model
- ClinicalTrials.gov ID
- NCT07398040
- Acronym / sponsor ID
- Anti-inf-AI
- Conditions
- Depression - Major Depressive Disorder, Anxiety
- Keywords
- Depression, Anxiety, Anti-inflammatory diet, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 16 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory diet | Experimental | Other: Anti-inflammatory diet |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-inflammatory dietWe will use an anti-inflammatory diet to assess its impact on physical, mental and cognitive health | Other | Anti-inflammatory diet |
| ControlNo intervention | Other | Control |
Primary outcome
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
9 secondary outcomes
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
Time frame: 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
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Depression - Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory diet in people with Depression - Major Depressive Disorder and Anxiety, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (Depression, Anxiety, Stress Scale; DASS-42) (time frame: From enrollment to the end of treatment at 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.