The Impact of the Mediterranean Diet on Anthropometric Indices, Lipid Profiles, Energy Metabolism Signaling Proteins and Inflammatory Cytokines in Psychiatric Patients With Metabolic Syndrome

King Saud University

Status: Completed

Conditions: Energy Metabolism; Psychiatric Disorders; Inflammatory Cytokines; Metabolic Syndrome (MetS); Lipid Profiles; Mediterranean Diet

Treatments: Other: Hospital diet; Other: Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07164014

95-EP-2023, KingFahadHospital

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 19 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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144 participants in 2 patient groups

Arm 1: Group 1

Experimental group

Description:

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.

Treatment:

Other: Mediterranean diet

Other: Hospital diet

Arm 2: Group 2

Experimental group

Description:

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.

Treatment:

Other: Mediterranean diet

Other: Hospital diet