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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome

NCT03271866

Schizophrenia

UNKNOWN NA

Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness

NCT02029989

Hyperlipidemia Diabetes Hypertension

COMPLETED NA

Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

NCT05548699

Diabetes Mellitus Depressive Disorder Depressive Symptoms +7 more

COMPLETED

Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness

NCT02167620

Diabetes Mellitus, Type 2 Schizophrenia

COMPLETED PHASE4

The Synergistic Effect of Hypoglycemic Index Diet on Refractory Schizophrenia

NCT04302636

Refractory Schizophrenia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Group 1

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.

Group Type EXPERIMENTAL

Mediterranean diet

Intervention Type 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)

Hospital diet

Intervention Type 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

Arm 2: Group 2

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.

Group Type EXPERIMENTAL

Mediterranean diet

Intervention Type 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)

Hospital diet

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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

Intervention Type OTHER