Effect of the Mediterranean Diet and Hypolipemic Reduction Diet in Combination With Exercise in Obese Croatian Population- 1-year Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Oxidative stress
研究概览
简要总结
The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 kg/m2
排除标准
- •newly diagnosed diabetes, hypertension or cardiovascular disease
- •change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study
- •insulin therapy
- •alcohol consumption >500 g of alcohol/week in the last year
- •pregnancy or breast feeding
- •use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)
研究组 & 干预措施
Mediterranean diet+physical activity
Mediterranean diet based on 1573 kcal/day with the goal of consumption of 30 ml/day of olive oil, 56g/week of nuts, 3-4 servings/week of fish, 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat
干预措施: Weight reduction program (Behavioral)
Hypolipemic reduction diet+physical activity
Hypolipemic reduction diet based on 1287 kcal/day with the goal of consumption of 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat, non-fat or low-fat dairy products
干预措施: Weight reduction program (Behavioral)
结局指标
主要结局
Oxidative stress
时间窗: The outcome measure is studied at baseline, 1 and 12 months
次要结局
- Body weight (kg)(The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months)
- Waist circumference (cm)(The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months)
- Fasting glycemia(The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months)
- Lipid profile (HLD, LDL, TC,)(The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months)
- Urate(The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months)
- Blood pressure (mmHg)(The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months)
- Physical activity level(The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months)
- Quality of life(The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months)
- Dietary intakes(The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months)
研究者
Prof. dr. sc. Velimir Božikov
Head of the Department of Endocrinology, Diabetes and Metabolism Disorders, Dubrava University Hospital
University of Zagreb