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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 19 Years – 59 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
OTHER	Mediterranean diet	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	Hospital diet	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

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-09-30
• Completion: 2024-10-05
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Saudi Arabia