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

Not Applicable

Completed

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

• Registration Number: NCT07164014
• Lead Sponsor: King Saud University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-05
• Study First Submitted: 2025-08-11
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Anthropometric measurement	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	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	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	Baseline, Week 8, week 11 and Week 18	Total cholesterol, HDL, LDL, and triglycerides measured via enzymatic colorimetric methods.

Secondary Outcome Measures

Name	Time	Method
Changes in Hormones	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
Change in Inflammatory Markers	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).

Trial Locations

Locations (1)

Mental Health Hospital; 🇸🇦 Riyadh, Saudi Arabia