Effects of Changes in Calcium Dietary Intake on Blood Pressure and Body Weight Control
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Antihypertensive effects as measured by BP measurements
研究概览
简要总结
Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from vegetables instead of dairy products, on blood pressure, body weight a main parameters of the glucose and lipid metabolisms.
This study is a randomized, parallel group trial that will be performed in the Outpatient Clinic. At least 150 patients with arterial hypertension and/or increased body weight (IMC> 28 kg/m2) will enter the study program. After a 3 month low-lipid low-salt diet that will be prescribed to all patients, they will be divided in two groups. The first will change the diet to that similar for total calories, percent composition of macronutrients and salt but enriched in calcium (about 1200 mg/daily) whilst the alternative group will continue the first diet. The observation period will be of 1 year with anthropometric (body weight and height, waist circumference), hemodynamic (blood pressure and heart rate) and metabolic (cholesterol, triglycerides, fasting blood glucose, uric acid, calcium, phosphorus, sodium and potassium) controls after 3-6 and 12 months.
详细描述
The DASH Study showed that the antihypertensive effects of a low-salt, low-lipid diet were significantly potentiated when the diet was enriched in calcium. This target may be reached either increasing the daily consumption of low-lipid milk and dairy products or increasing the daily consumption of calcium-rich vegetables.
In the Italian population the mean daily consumption of calcium is rather low, not exceeding 700 mg/daily whilst it would be desirable a daily consumption of 1200 mg/daily. Unfortunately there are in Italy very few dairy products (particularly low-lipid cheese) that would ensure a variable and palatable calcium-rich diet.
Aims of the present study are:
- to prepare a low-sodium (about 3 g/daily) diet enrich in calcium (about 1200 mg/daily) and to compare the effects on blood pressure with those of a low-sodium diet similar to it in macronutrients but with a calcium content typical of the Mediterranean diet (no more than 700 mg/daily) (see Table 1);
- to verify if this diet is able to improve the control of body weight and of the main parameters of the glucose and lipid metabolisms;
- to evaluate if this diet is palatable enough to be prescribed in a long term study.
Patients:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 30-70 years
- •IMC >28 and < 35 kg/m2
- •pharmacological treatment unchanged in the last 3 months
排除标准
- •chronic kidney disease
- •liver or chronic inflammatory bowel disease
结局指标
主要结局
Antihypertensive effects as measured by BP measurements
时间窗: after 3-months of dietary treatment
Measurements of blood pressure by sphygmomanometer.
次要结局
- Effects on glucose metabolism as measured by fasting blood glucose(after 3 months of dietary treatment)
- Effects on body weight as measured by scale(after 3-months of dietary treatment)
- Effects on lipid metabolism as measured by measurements of serum cholesterol, triglycerides and HDL-cholesterol(after 3 months of dietary treatment)
研究者
Ferrara Liberato Aldo
Associate Professor of Medicine
Federico II University