Comparative Effects of Three Dietary Strategies on Body Composition, Metabolic Markers, and Metabolic Syndrome in Adults With Overweight/Obesity: A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI, kg/m²) assessed by weight (Tanita MC-780MA bioimpedance scale) and height (Seca stadiometer) from baseline to 12 weeks
研究概览
简要总结
This study aims to compare the effects of three dietary interventions-a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet-on body composition, metabolic health markers, and metabolic syndrome remission in adults with overweight or obesity. A total of 45 participants will be randomly assigned to one of the three diets for 12 weeks, with regular follow-up by dietitians. Measurements will include weight, body fat, muscle mass, waist and hip circumference, blood pressure, and blood tests to assess glucose, cholesterol, inflammation, and other metabolic parameters. The findings will help determine whether one dietary pattern is more effective than others in improving short-term health outcomes in this population.
详细描述
Detailed Description:
This randomized, controlled, parallel-group pilot clinical trial will evaluate the effects of three different hypocaloric dietary strategies on body composition, metabolic markers, and metabolic syndrome remission in adults with overweight or obesity.
Background and Rationale Overweight and obesity are highly prevalent in Europe and are associated with an increased risk of metabolic syndrome, cardiovascular disease, type 2 diabetes, and obesity-related cancers. Dietary interventions are a cornerstone in their management, but the optimal macronutrient composition for improving short-term metabolic outcomes remains unclear. This study investigates the comparative impact of a traditional Mediterranean diet, a Mediterranean low-carbohydrate diet, and a high-protein diet over a 12-week period.
Study Design A total of 45 participants aged 18-65 years with a body mass index (BMI) ≥25 kg/m² will be recruited through online advertisements and primary care referrals. After eligibility screening and informed consent, participants will be randomly allocated (1:1:1) to one of the three dietary intervention arms.
Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20-70 years
- •Body mass index (BMI) ≥ 25 kg/m² (overweight or obesity)
- •Stable body weight (± 2 kg) in the last 3 months prior to screening
- •Willingness to follow one of the prescribed dietary interventions for 12 weeks
- •Ability to attend scheduled follow-up visits and complete study assessments
- •Provided written informed consent prior to study participation
排除标准
- •Diagnosis of type 1 diabetes, cardiovascular disease, cancer, chronic kidney disease, liver disease, or other serious chronic conditions that could interfere with the intervention
- •Pregnancy or breastfeeding
- •Current participation in another clinical trial
- •History of bariatric surgery or weight-loss program within the past 6 months
- •Use of medications known to affect body weight, metabolism, or appetite (e.g., glucocorticoids, weight-loss drugs, antipsychotics)
- •Any food allergy or intolerance that would preclude adherence to the assigned diet
- •Alcohol or substance abuse
- •Any condition or circumstance that, in the opinion of the investigators, would make the participant unsuitable for the study
结局指标
主要结局
Change in Body Mass Index (BMI, kg/m²) assessed by weight (Tanita MC-780MA bioimpedance scale) and height (Seca stadiometer) from baseline to 12 weeks
时间窗: Baseline and week 12
BMI will be calculated as weight (kg) divided by height (m²). Weight will be measured without shoes using a Tanita MC-780MA multi-frequency bioelectrical impedance analyzer, and height will be measured using a calibrated Seca wall-mounted stadiometer.
次要结局
- Change in Fat Mass Percentage (%) assessed by Tanita MC-780MA bioelectrical impedance analyzer from baseline to 12 weeks(Baseline and week 12)
- Change in Metabolic Syndrome Status (yes/no) defined by IDF criteria from baseline to 12 weeks(Baseline and week 12)
- Change in Fat-Free Mass Percentage (%) assessed by Tanita MC-780MA bioelectrical impedance analyzer from baseline to 12 weeks(Baseline and week 12)
- Change in glycated hemoglobin (HbA1c, %) from baseline to 12 weeks(Baseline and week 12)
- Change in serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) from baseline to 12 weeks(Baseline and week 12)
- Change in fasting glucose (mg/dL) from baseline to 12 weeks(Baseline and week 12)
- Change in high-sensitivity C-reactive protein (hs-CRP, mg/dL) from baseline to 12 weeks(Baseline and week 12)
- Change in serum uric acid (mg/dL) from baseline to 12 weeks(Baseline and week 12)