Energy Metabolism, Inflammatory Cytokines, Lipid Profiles, Mediterranean Diet, Metabolic Syndrome (MetS), Psychiatric Disorders
Conditions
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.
Interventions
OTHERMediterranean 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)
OTHERHospital 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
Sponsors
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Saudi Arabia
Outcome results
None listed