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

NCT07164014 | Completed DMC

• 1 other identifier: 95-EP-2023, KingFahadHospital
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  Baseline, Week 8, week 11 and Week 18

• Change in Serum Lipid Profile

  Total cholesterol, HDL, LDL, and triglycerides measured via enzymatic colorimetric methods.

  Baseline, Week 8, week 11 and Week 18

Secondary Outcomes (2)

• Changes in Hormones

  Baseline, Week 8, week 11 and Week 18

• Change in Inflammatory Markers

  Baseline, Week 8, week 11 and Week 18

Study Arms (2)

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.

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.

Other: Mediterranean diet; Other: Hospital diet

Interventions

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)

Also known as: Arm 1: Group 1, Arm 2: Group 2

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

Also known as: Arm 2: Group 2, Arm 1: Group 1

Arm 1: Group 1; Arm 2: Group 2

Eligibility Criteria

• Age: 19 Years - 59 Years
• Gender Eligibility Details: Written informed consent was obtained from the participant or their legal guardian on behalf of the study participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Mental Health Hospital

Riyadh, 36445, Saudi Arabia

Location

MeSH Terms

Conditions

Metabolic Syndrome; Mental Disorders

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Of Clinical Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 9, 2025
• Study Start: May 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 5, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)