Dietary Modifications, Like Changing Macronutrient Distribution and Improving Food Quality, Are Main Therapeutic Approaches for Managing Oxidative Stress, Inflammation, and Metabolic Syndrome: Mediterranean Diet is Scientifically Endorsed as Promoting Healthy and Reducing the Risk of Cognitive Decline
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King Saud University
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Change in Anthropometric measurement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 59 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Mediterranean diet (Other)
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.
Intervention: Hospital diet (Other)
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.
Intervention: Mediterranean diet (Other)
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.
Intervention: Hospital diet (Other)
Outcomes
Primary Outcomes
Change in Anthropometric measurement
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 8, week 11 and Week 18
Total cholesterol, HDL, LDL, and triglycerides measured via enzymatic colorimetric methods.
Secondary Outcomes
- Changes in Hormones(Baseline, Week 8, week 11 and Week 18)
- Change in Inflammatory Markers(Baseline, Week 8, week 11 and Week 18)
Investigators
Ali Abdullah Alyousef
Head Of Clinical Nutrition
King Saud University