Severe Mental IllnessNCT07844837
Ultra-Processed Foods, DASH Diet, and Well-Being in Severe Mental Illness
An observational study of Severe Mental Illness, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the associations of ultra-processed food (UPF) consumption and DASH diet adherence with psychological well-being, emotional eating, and inflammatory markers in individuals with severe mental illness (SMI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Mental Illness
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults aged 18-65 years with a psychiatric disorder confirmed according to DSM-5 or ICD-10 diagnostic criteria. Participants were clinically stable and had been receiving treatment for at least 1 month. A total of 105 participants were initially included in the study, while 92 participants were included in the final analyses after excluding those with incomplete data. No control group was included.
Who may be able to join
- Aged 18-65 years
- Having a psychiatric disorder confirmed according to DSM-5 or ICD-10 diagnostic criteria
- Being clinically stable
- Having received treatment for at least 1 month
Who cannot join
- Severe cognitive impairment or a diagnosis of dementia
- Experiencing an acute psychiatric crisis
- Pregnancy or breastfeeding
- Having a medical condition that severely restricts dietary intake (e.g., renal failure or ongoing cancer treatment)
- A history of major surgery within the previous 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University, Faculty of Health Sciences
Bolu
About this study
Official title: Ultra-Processed Food Consumption and DASH Diet Quality in Severe Mental Illness: Associations With Psychological and Inflammatory Outcomes
This study aimed to investigate the associations of ultra-processed food (UPF) consumption and DASH diet adherence with psychological well-being, emotional eating, and inflammatory markers in individuals with severe mental illness (SMI). This cross-sectional study included clinically stable individuals aged 18-65 years who had been diagnosed with a psychiatric disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Participants were selected using purposive sampling. Data were collected face-to-face using a Sociodemographic Information Form, the Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF), the Dietary Approaches to Stop Hypertension Quality (DASH-Q), the Psychological Well-Being Scale, and the Emotional Eating Scale. Anthropometric measurements and routine biochemical data, including fasting glucose, C-reactive protein (CRP), and complete blood count parameters, were recorded.
Read the detailed description
Objective: This study aimed to investigate the associations of ultra-processed food (UPF) consumption and DASH diet adherence with psychological well-being, emotional eating, and inflammatory markers in individuals with severe mental illness (SMI).
Methods: This cross-sectional study included clinically stable individuals aged 18-65 years who had been diagnosed with a psychiatric disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Participants were selected using purposive sampling. Data were collected face-to-face using a Sociodemographic Information Form, the Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF), the Dietary Approaches to Stop Hypertension Quality (DASH-Q), the Psychological Well-Being Scale, and the Emotional Eating Scale. Anthropometric measurements and routine biochemical data, including fasting glucose, C-reactive protein (CRP), and complete blood count parameters, were recorded. The relationships among dietary measures, psychological outcomes, anthropometric measurements, and biochemical parameters were evaluated using appropriate statistical analyses.
- Conditions
- Severe Mental Illness
- Being tested
- No intervention (observational study)
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Participants with severe mental illness | This study included 105 adult participants with severe mental illness. No control group was included. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Form
Sociodemographic characteristics of the individuals (age, constipation status, presence of comorbidities, gender, smoking and alcohol use) were questioned.
Measured: 4 months
Body weight (BW)
BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.
Measured: 4 months
Height
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Measured: 4 months
Body Mass Index (BMI)
BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).
Measured: 4 months
C-Reactive Protein (CRP)
CRP levels were measured using routine laboratory procedures in outpatient visits.
Measured: 4 months
Hemoglobin (Hb)
Hemoglobin (Hb) levels were measured using routine laboratory procedures in outpatient visits.
Measured: 4 months
Neutrophil
Neutrophil levels were measured using routine laboratory procedures in outpatient visits.
Measured: 4 months
Lymphocyte
Lymphocyte levels were measured using routine laboratory procedures in outpatient visits.
Measured: 4 months
Systemic immune-inflammation index (SII)
Systemic immune-inflammation index (SII)
Measured: 4 months
Neutrophil-to-lymphocyte ratio (NLR)
The neutrophil-to-lymphocyte ratio (NLR), a hematological marker of systemic inflammation, was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count.
Measured: 4 months
The Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF)
The Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF) is a brief dietary assessment tool developed to evaluate the frequency of consumption of highly processed foods. The questionnaire assesses the consumption of various food groups commonly classified as highly processed and provides an overall score reflecting the frequency of highly processed food consumption. sQ-HPF is an 11-item dietary screening tool used to assess highly processed food consumption. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 11. Higher scores indicate higher consumption of highly processed foods and therefore a worse outcome. A total score of 6 or higher indicates a high level of highly processed food consumption.
Measured: 4 months
The Dietary Approaches to Stop Hypertension Quality (DASH-Q)
The Dietary Approaches to Stop Hypertension Quality (DASH-Q) is a dietary assessment tool designed to evaluate adherence to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. The scale assesses the consumption of key food groups and nutrients emphasized in the DASH diet, with higher scores indicating greater adherence to the DASH dietary pattern. DASH-Q is an 11-item dietary assessment tool designed to evaluate adherence to the DASH dietary pattern. Each item is scored from 0 to 7 according to the number of days the corresponding food group was consumed during the previous 7 days, yielding a total score ranging from 0 to 77. Total scores are classified as low (0-32), moderate (33-51), or high (52-77) diet quality. Higher scores indicate greater adherence to the DASH dietary pattern and therefore represent a better outcome.
Measured: 4 months
Emotional Eating Scale (EES)
The Emotional Eating Scale (EES) is a self-report instrument designed to assess the tendency to eat in response to emotional states. It evaluates eating behavior associated with various emotional states, with higher scores indicating a greater tendency toward emotional eating. EES is a 16-item scale consisting of three subscales: anger, anxiety, and depression. Each item is rated on a 5-point Likert scale ranging from 1 (no desire to eat) to 5 (an overwhelming urge to eat). There are no reverse-scored items. The total score ranges from 16 to 80, with higher scores indicating a higher level of emotional eating behavior and therefore a worse outcome.
Measured: 4 months
Psychological Well-being Scale
The Psychological Well-Being Scale is a self-report instrument designed to assess individuals' overall psychological well-being and positive psychological functioning. Higher scores indicate higher levels of psychological well-being.The Psychological Well-Being Scale is an 8-item scale designed to assess individuals' psychological well-being. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 8 to 56, with higher scores indicating greater psychological resources and strengths and a more positive evaluation of oneself in important areas of functioning, therefore representing a better outcome.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Apr 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurefşan KONYALIGİL ÖZTÜRK, Abant Izzet Baysal University
- Investigators
- Nurefşan Konyalıgil Öztürk, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844837
- Sponsor's protocol ID
- AIBU-BD-NKÖ-05
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Processed Food Consumption and DASH Diet Quality in Severe Mental Illness: Associations With Psychological and Inflammatory Outcomes
- ClinicalTrials.gov ID
- NCT07844837
- Acronym / sponsor ID
- AIBU-BD-NKÖ-05
- Conditions
- Severe Mental Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 28 Sep 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.
This study aimed to investigate the associations of ultra-processed food (UPF) consumption and DASH diet adherence with psychological well-being, emotional eating, and inflammatory markers in individuals with severe mental illness (SMI). This cross-sectional study included clinically stable individuals aged 18-65 years who had been diagnosed with a psychiatric disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Participants were selected using purposive sampling. Data were collected face-to-face using a Sociodemographic Information Form, the Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF), the Dietary Approaches to Stop Hypertension Quality (DASH-Q), the Psychological Well-Being Scale, and the Emotional Eating Scale. Anthropometric measurements and routine biochemical data, including fasting glucose, C-reactive protein (CRP), and complete blood count parameters, were recorded.
Detailed description
Objective: This study aimed to investigate the associations of ultra-processed food (UPF) consumption and DASH diet adherence with psychological well-being, emotional eating, and inflammatory markers in individuals with severe mental illness (SMI).
Methods: This cross-sectional study included clinically stable individuals aged 18-65 years who had been diagnosed with a psychiatric disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or the International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Participants were selected using purposive sampling. Data were collected face-to-face using a Sociodemographic Information Form, the Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF), the Dietary Approaches to Stop Hypertension Quality (DASH-Q), the Psychological Well-Being Scale, and the Emotional Eating Scale. Anthropometric measurements and routine biochemical data, including fasting glucose, C-reactive protein (CRP), and complete blood count parameters, were recorded. The relationships among dietary measures, psychological outcomes, anthropometric measurements, and biochemical parameters were evaluated using appropriate statistical analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with severe mental illness | – | Other: No intervention (observational study)This study included 105 adult participants with severe mental illness. No control group was included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults aged 18-65 years with a psychiatric disorder confirmed according to DSM-5 or ICD-10 diagnostic criteria. Participants were clinically stable and had been receiving treatment for at least 1 month. A total of 105 participants were initially included in the study, while 92 participants were included in the final analyses after excluding those with incomplete data. No control group was included.
Key inclusion criteria (4 listed)
- Aged 18-65 years
- Having a psychiatric disorder confirmed according to DSM-5 or ICD-10 diagnostic criteria
- Being clinically stable
- Having received treatment for at least 1 month
Key exclusion criteria (5 listed)
- Severe cognitive impairment or a diagnosis of dementia
- Experiencing an acute psychiatric crisis
- Pregnancy or breastfeeding
- Having a medical condition that severely restricts dietary intake (e.g., renal failure or ongoing cancer treatment)
- A history of major surgery within the previous 3 months
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 |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Participants with severe mental illness |
Primary outcome
Questionnaire Form
Time frame: 4 months
Sociodemographic characteristics of the individuals (age, constipation status, presence of comorbidities, gender, smoking and alcohol use) were questioned.
Body weight (BW)
Time frame: 4 months
BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.
Height
Time frame: 4 months
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Body Mass Index (BMI)
Time frame: 4 months
BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).
C-Reactive Protein (CRP)
Time frame: 4 months
CRP levels were measured using routine laboratory procedures in outpatient visits.
Hemoglobin (Hb)
Time frame: 4 months
Hemoglobin (Hb) levels were measured using routine laboratory procedures in outpatient visits.
Neutrophil
Time frame: 4 months
Neutrophil levels were measured using routine laboratory procedures in outpatient visits.
Lymphocyte
Time frame: 4 months
Lymphocyte levels were measured using routine laboratory procedures in outpatient visits.
Systemic immune-inflammation index (SII)
Time frame: 4 months
Systemic immune-inflammation index (SII)
Neutrophil-to-lymphocyte ratio (NLR)
Time frame: 4 months
The neutrophil-to-lymphocyte ratio (NLR), a hematological marker of systemic inflammation, was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count.
The Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF)
Time frame: 4 months
The Screening Questionnaire of Highly Processed Food Consumption (SQ-HPF) is a brief dietary assessment tool developed to evaluate the frequency of consumption of highly processed foods. The questionnaire assesses the consumption of various food groups commonly classified as highly processed and provides an overall score reflecting the frequency of highly processed food consumption. sQ-HPF is an 11-item dietary screening tool used to assess highly processed food consumption. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 11. Higher scores indicate higher consumption of highly processed foods and therefore a worse outcome. A total score of 6 or higher indicates a high level of highly processed food consumption.
The Dietary Approaches to Stop Hypertension Quality (DASH-Q)
Time frame: 4 months
The Dietary Approaches to Stop Hypertension Quality (DASH-Q) is a dietary assessment tool designed to evaluate adherence to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. The scale assesses the consumption of key food groups and nutrients emphasized in the DASH diet, with higher scores indicating greater adherence to the DASH dietary pattern. DASH-Q is an 11-item dietary assessment tool designed to evaluate adherence to the DASH dietary pattern. Each item is scored from 0 to 7 according to the number of days the corresponding food group was consumed during the previous 7 days, yielding a total score ranging from 0 to 77. Total scores are classified as low (0-32), moderate (33-51), or high (52-77) diet quality. Higher scores indicate greater adherence to the DASH dietary pattern and therefore represent a better outcome.
Emotional Eating Scale (EES)
Time frame: 4 months
The Emotional Eating Scale (EES) is a self-report instrument designed to assess the tendency to eat in response to emotional states. It evaluates eating behavior associated with various emotional states, with higher scores indicating a greater tendency toward emotional eating. EES is a 16-item scale consisting of three subscales: anger, anxiety, and depression. Each item is rated on a 5-point Likert scale ranging from 1 (no desire to eat) to 5 (an overwhelming urge to eat). There are no reverse-scored items. The total score ranges from 16 to 80, with higher scores indicating a higher level of emotional eating behavior and therefore a worse outcome.
Psychological Well-being Scale
Time frame: 4 months
The Psychological Well-Being Scale is a self-report instrument designed to assess individuals' overall psychological well-being and positive psychological functioning. Higher scores indicate higher levels of psychological well-being.The Psychological Well-Being Scale is an 8-item scale designed to assess individuals' psychological well-being. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 8 to 56, with higher scores indicating greater psychological resources and strengths and a more positive evaluation of oneself in important areas of functioning, therefore representing a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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. This study is not recruiting at the moment.
Nurefşan Konyalıgil Öztürk principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Illness, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Questionnaire Form (time frame: 4 months). The study lists 14 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 28 Sep 2026.