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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in Anthropometric measurement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adults with psychiatric conditions
- •Diagnosed with three components of metabolic syndrome
排除标准
- •cognitive or physical impairments that made it difficult to gather all pertinent information
- •Non-Hospitalized patients
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Hospital diet (Other)
结局指标
主要结局
Change in Anthropometric measurement
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline, Week 8, week 11 and Week 18
Total cholesterol, HDL, LDL, and triglycerides measured via enzymatic colorimetric methods.
次要结局
- Changes in Hormones(Baseline, Week 8, week 11 and Week 18)
- Change in Inflammatory Markers(Baseline, Week 8, week 11 and Week 18)
研究者
Ali Abdullah Alyousef
Head Of Clinical Nutrition
King Saud University