Metabolic Syndrome (MetS)NCT07164014
The Impact of the Mediterranean Diet on Anthropometric Indices, Lipid Profiles, Energy Metabolism Signaling Proteins and Inflammatory Cytokines in Psychiatric Patients With Metabolic Syndrome
A study testing Mediterranean diet and Hospital diet in people with Metabolic Syndrome (MetS) and Psychiatric Disorders, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Background: Dietary modifications, like changing macronutrient distribution and improving food quality, are the main therapeutic approaches for managing oxidative stress, inflammation, and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 19 to 59 years
- Conditions the study is for
- Metabolic Syndrome (MetS), Psychiatric Disorders, Mediterranean Diet
- What is being tested?
- Mediterranean diet and Hospital diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2024to 5 Oct 2024
- Phase
- Interventional
- 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 19 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hospitalized adults with psychiatric conditions
- Diagnosed with three components of metabolic syndrome
Who cannot join
- cognitive or physical impairments that made it difficult to gather all pertinent information
- Non-Hospitalized patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Modifications, Like Changing Macronutrient Distribution and Improving Food Quality, Are Main Therapeutic Approaches for Managing Oxidative Stress, Inflammation, and Metabolic Syndrome: Mediterranean Diet is Scientifically Endorsed as Promoting Healthy and Reducing the Risk of Cognitive Decline
Background: Dietary modifications, like changing macronutrient distribution and improving food quality, are the main therapeutic approaches for managing oxidative stress, inflammation, and metabolic syndrome. Mediterranean diet is scientifically endorsed as promoting healthy aging and reducing the risk of cognitive decline when compared to the Western-style diet pattern. Objective: Analyzing the beneficial effect of the Mediterranean diet (MD) on anthropometric indices, inflammatory markers, lipid profiles in psychiatric patients with metabolic syndrome, compared to the standard hospital diet (HD). Methods: The study was designed as a crossover study; 15 male and 15 female participants with psychiatric disorders were enrolled, and they were intervened with either MD or HD for 8 weeks. Anthropometric parameters, inflammatory cytokines, lipid profile, and metabolic markers were measured with two stages of pre- and post-intervention.
- Conditions
- Metabolic Syndrome (MetS), Psychiatric Disorders, Mediterranean Diet, Inflammatory Cytokines, Energy Metabolism, Lipid Profiles
- Being tested
- Mediterranean diet, Hospital diet
- Medical subject headings
- Metabolic Syndrome, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
Also called Arm 1: Group 1, Arm 2: Group 2
Mediterranean Diet Total Calories: ~1,980 kcal Protein: ~110 g Carbohydrates: ~132 g Fat: ~117 g Diet Type: Mediterranean: Moderate-calorie, high in unsaturated fats, includes fermented dairy Omega-3 Sources: Present: Fish, Olive Oil, Nuts Oil/Fat Types: Olive oil, tahini, nuts (mostly monounsaturated \& polyunsaturated)
Hospital dietOther
Also called Arm 2: Group 2, Arm 1: Group 1
Hospital diet Total Calories: ~3,100 kcal Protein: ~160 g Carbohydrates: ~280 g Fat: ~150 g Diet Type: High Protein, High Calorie: High in saturated fats, refined carbs, and animal proteins Omega-3 Sources: Minimal: Mostly absent Oil/Fat Types: Animal fats (saturated), dairy fat, minimal unsaturated fat
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Group 1 | Experimental | The trial is a randomized 2×2 crossover where each participant receives both interventions separated by a washout.
Interventions:
Mediterranean Diet - Provided for 8 weeks Hospital Diet - Provided for 8 weeks after a 2-week washout. Receives: Other: Mediterranean diet; Other: Hospital diet |
| Arm 2: Group 2 | Experimental | The trial is a randomized 2×2 crossover where each participant receives both interventions separated by a washout.
Interventions:
Hospital Diet - Provided for 8 weeks, includes standard hospital meals
Mediterranean Diet - Provided for 8 weeks after a 2-week washout. Receives: Other: Mediterranean diet; Other: Hospital diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anthropometric measurement
Four visits were conducted to measure anthropometric parameters using the Tanita Model BC-418® body composition analyzer (Tokyo, Japan). The participants were positioned standing, and electrodes were affixed to their hands and feet. Before the test, participants were allowed to fast for 10 h, and following each measurement, their palms and soles were cleansed. Height (cm), body weight (Kg), body mass index (BMI), abdominal circumference (AC), percentage body fat (PBF), muscle mass percentage (MMP), and visceral fat (VF) were automatically measured by the preprogrammed instrument when it was connected to an ultrasonic height meter.
Measured: Baseline, Week 8, 11 week, and Week 18
Blood pressure
Blood pressure was monitored three times a day, specifically between 8:00 am and 10:00 am, 2:00 pm and 4:00 pm, and from 6:00 pm. to 8:00 PM. All hypertensive readings were taken at least 30 minutes following each meal using an Omron HEM-7136 blood pressure monitor (Omron Health Care Co, Ltd, Matsusaka, Japan). Triplicate readings were collected at each time point on the upper right arm with a one-minute interval.
Measured: Baseline, Week 8, week 11, and Week 18
Change in Fasting Blood Glucose
Serum glucose measured via venous blood sample after 10-hour overnight fast, analyzed using automated chemistry analyzer.
Measured: Baseline, Week 8, week 11 and Week 18
Change in Serum Lipid Profile
Total cholesterol, HDL, LDL, and triglycerides measured via enzymatic colorimetric methods.
Measured: Baseline, Week 8, week 11 and Week 18
Secondary outcomes (2)
Changes in Hormones
Insulin, testosterone, serotonin, norepinephrine, thyroid stimulating hormone, thyroxine T4, triiodothyronine T3, prolactin, and cortisol. A standard solution was used to produce a standard curve for all hormones
Measured: Baseline, Week 8, week 11 and Week 18
Change in Inflammatory Markers
Pro-inflammatory cytokines (IL-1β, IL-12, and TNF-α) and anti-inflammatory cytokines (IL-6, IL-10, and IL-31) were quantitatively analyzed using the ELISA method.
The concentrations of plasma α-melanocyte stimulating hormone (α-MSH), carbohydrate response element binding protein (ChREBP), fibroblast growth factor-21 (FGF-21), and agouti-related protein (AgRP) were also analyzed using the ELISA method following the manufacturer's protocol (Bioassay Technology Laboratory, Shanghai, China).
Measured: Baseline, Week 8, week 11 and Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 May 2024
- Primary completion30 Sep 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome (MetS)Studies 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
- Crossover
- Model description
- The trial included two stages of 8-week intervention periods separated by a 2-week washout period. The hospital kitchen provided the preferred food list, menu, and MD plan design for the patients enrolled in this diet.A certified registered dietician analyzed the data. All 30 psychiatric patients participated in the MD intervention for eight weeks after consuming their regular diets during the washout phase. Following the 14-day washing period, the same group was given a hospitalized diet as a control diet that included medication supplements. An 18-week 2 × 2 crossover design was used in the study. All the anthropometric measurements and blood profiles were performed at baseline (pre-intervention), and after week 8 (post-intervention) after a 10-h overnight fast.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abdullah Alyousef, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164014
- Sponsor's protocol ID
- 95-EP-2023, KingFahadHospital
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Modifications, Like Changing Macronutrient Distribution and Improving Food Quality, Are Main Therapeutic Approaches for Managing Oxidative Stress, Inflammation, and Metabolic Syndrome: Mediterranean Diet is Scientifically Endorsed as Promoting Healthy and Reducing the Risk of Cognitive Decline
- ClinicalTrials.gov ID
- NCT07164014
- Acronym / sponsor ID
- 95-EP-2023, KingFahadHospital
- Conditions
- Metabolic Syndrome (MetS), Psychiatric Disorders, Mediterranean Diet, Inflammatory Cytokines, Energy Metabolism, Lipid Profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 9 Sep 2025 (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.
Background: Dietary modifications, like changing macronutrient distribution and improving food quality, are the main therapeutic approaches for managing oxidative stress, inflammation, and metabolic syndrome. Mediterranean diet is scientifically endorsed as promoting healthy aging and reducing the risk of cognitive decline when compared to the Western-style diet pattern. Objective: Analyzing the beneficial effect of the Mediterranean diet (MD) on anthropometric indices, inflammatory markers, lipid profiles in psychiatric patients with metabolic syndrome, compared to the standard hospital diet (HD). Methods: The study was designed as a crossover study; 15 male and 15 female participants with psychiatric disorders were enrolled, and they were intervened with either MD or HD for 8 weeks. Anthropometric parameters, inflammatory cytokines, lipid profile, and metabolic markers were measured with two stages of pre- and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The trial included two stages of 8-week intervention periods separated by a 2-week washout period. The hospital kitchen provided the preferred food list, menu, and MD plan design for the patients enrolled in this diet.A certified registered dietician analyzed the data. All 30 psychiatric patients participated in the MD intervention for eight weeks after consuming their regular diets during the washout phase. Following the 14-day washing period, the same group was given a hospitalized diet as a control diet that included medication supplements. An 18-week 2 × 2 crossover design was used in the study. All the anthropometric measurements and blood profiles were performed at baseline (pre-intervention), and after week 8 (post-intervention) after a 10-h overnight fast.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Group 1 | Experimental | Other: Mediterranean diet, Other: Hospital dietThe trial is a randomized 2×2 crossover where each participant receives both interventions separated by a washout. Interventions: Mediterranean Diet - Provided for 8 weeks Hospital Diet - Provided for 8 weeks after a 2-week washout. |
| Arm 2: Group 2 | Experimental | Other: Mediterranean diet, Other: Hospital dietThe trial is a randomized 2×2 crossover where each participant receives both interventions separated by a washout. Interventions: Hospital Diet - Provided for 8 weeks, includes standard hospital meals Mediterranean Diet - Provided for 8 weeks after a 2-week washout. |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hospitalized adults with psychiatric conditions
- Diagnosed with three components of metabolic syndrome
Key exclusion criteria (2 listed)
- cognitive or physical impairments that made it difficult to gather all pertinent information
- Non-Hospitalized patients
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 |
|---|---|---|
| Mediterranean dietAlso: Arm 1: Group 1, Arm 2: Group 2Mediterranean Diet Total Calories: ~1,980 kcal Protein: ~110 g Carbohydrates: ~132 g Fat: ~117 g Diet Type: Mediterranean: Moderate-calorie, high in unsaturated fats, includes fermented dairy Omega-3 Sources: Present: Fish, Olive Oil, Nuts Oil/Fat Types: Olive oil, tahini, nuts (mostly monounsaturated \& polyunsaturated) | Other | Arm 1: Group 1, Arm 2: Group 2 |
| Hospital dietAlso: Arm 2: Group 2, Arm 1: Group 1Hospital diet Total Calories: ~3,100 kcal Protein: ~160 g Carbohydrates: ~280 g Fat: ~150 g Diet Type: High Protein, High Calorie: High in saturated fats, refined carbs, and animal proteins Omega-3 Sources: Minimal: Mostly absent Oil/Fat Types: Animal fats (saturated), dairy fat, minimal unsaturated fat | Other | Arm 1: Group 1, Arm 2: Group 2 |
Primary outcome
Change in Anthropometric measurement
Time frame: Baseline, Week 8, 11 week, and Week 18
Four visits were conducted to measure anthropometric parameters using the Tanita Model BC-418® body composition analyzer (Tokyo, Japan). The participants were positioned standing, and electrodes were affixed to their hands and feet. Before the test, participants were allowed to fast for 10 h, and following each measurement, their palms and soles were cleansed. Height (cm), body weight (Kg), body mass index (BMI), abdominal circumference (AC), percentage body fat (PBF), muscle mass percentage (MMP), and visceral fat (VF) were automatically measured by the preprogrammed instrument when it was connected to an ultrasonic height meter.
Blood pressure
Time frame: Baseline, Week 8, week 11, and Week 18
Blood pressure was monitored three times a day, specifically between 8:00 am and 10:00 am, 2:00 pm and 4:00 pm, and from 6:00 pm. to 8:00 PM. All hypertensive readings were taken at least 30 minutes following each meal using an Omron HEM-7136 blood pressure monitor (Omron Health Care Co, Ltd, Matsusaka, Japan). Triplicate readings were collected at each time point on the upper right arm with a one-minute interval.
Change in Fasting Blood Glucose
Time frame: Baseline, Week 8, week 11 and Week 18
Serum glucose measured via venous blood sample after 10-hour overnight fast, analyzed using automated chemistry analyzer.
Change in Serum Lipid Profile
Time frame: Baseline, Week 8, week 11 and Week 18
Total cholesterol, HDL, LDL, and triglycerides measured via enzymatic colorimetric methods.
2 secondary outcomes
Changes in Hormones
Time frame: Baseline, Week 8, week 11 and Week 18
Change in Inflammatory Markers
Time frame: Baseline, Week 8, week 11 and Week 18
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 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Mediterranean diet and Hospital diet in people with Metabolic Syndrome (MetS) and Psychiatric Disorders, run by King Saud University at 1 site in Saudi Arabia.
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 2 inclusion and 2 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 9 Sep 2025. 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 Saudi Arabia. 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?
Change in Anthropometric measurement (time frame: Baseline, Week 8, 11 week, and Week 18). The study lists 4 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 Sep 2025.