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Completed

NCT Number: 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

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.

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Key information

Conditions

Metabolic Syndrome (MetS) Energy Metabolism Glucose Metabolism Disorders Hyperinsulinism Inflammatory Cytokines Insulin Resistance Lipid Profiles Mediterranean Diet Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Psychiatric Disorders

Age range

19 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Hospital

Riyadh, 36445, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized adults with psychiatric conditions
  • Diagnosed with three components of metabolic syndrome

Exclusion criteria

  • cognitive or physical impairments that made it difficult to gather all pertinent information
  • Non-Hospitalized patients

Treatment and study plan

Mediterranean Diet

Other

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)

Other names: Arm 1: Group 1, Arm 2: Group 2

Hospital diet

Other

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

Other names: Arm 2: Group 2, Arm 1: Group 1

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Changes in Hormones

    Time frame: Baseline, Week 8, week 11 and Week 18

    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

  2. Change in Inflammatory Markers

    Time frame: Baseline, Week 8, week 11 and Week 18

    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).

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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