Design and Testing Efficacy of Blood Pressure and Glucose Lowering Diet for Taiwanese Pre-/1st Staged Hypertension Patients and/or Pre-diabetes Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- blood pressure
研究概览
简要总结
Prevalence rates of hypertension and diabetes are high in Taiwan. Little attention is given to evidence-based dietary therapy in Taiwan. Patients, after confirmed diagnosis, are mostly prescribed with medications without comprehensive instructions on dietary therapy. DASH diet has been proven to be an effective dietary approach to reduce blood pressure for hypertension patients in US. However, dietary difference and patient profiles across countries are evident. In addition, hypertensive patients are often combined with hyperglycemia. Carbohydrate burden of DASH diet may be higher than most dietitians desire. Therefore, the investigators in tend to design a Taiwanese DASH diet and a lower carbohydrate DASH diet and test their efficacy on both blood pressure and fasting glucose lowering.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-65 years, weight 50-80 kg(±5kg)
- •Two blood pressure readings and fasting blood glucose measurements:
- •fasting blood glucose of 100-125 ml/dL and not using antidiabetic medication.
- •systolic blood pressure of 130-159 mmHg or diastolic blood pressure of 85-99 mmHg and not using antihypertensive medication.
排除标准
- •(a) taking blood glucose lowering, antihypertensive or oral steroid medications.
- •(b) history of stroke, cardiovascular disease, abnormal liver function, cancer, stomach ulcer, inflammatory bowel disease or other chronic diseases that will influence the diet of participants.
- •(c) Major surgery in the past year or about to undergo major surgery.
- •(d) Is the holder of a major illness card.
- •(e) Takes antipsychotics.
- •(f) Harmful drinker (more than 14 drinks per week)
- •(g) Has food allergies or food intolerance.
- •(h) Pregnant or breastfeeding.
- •(i) Unwilling to cease intake of vitamin or mineral supplements or antacids containing magnesium or calcium for the duration of the study.
- •(j) Other medications or physiological states influencing the absorption of nutrients.
- •(k) Other individuals deemed unsuitable to participate in the intervention by their treating physician.
结局指标
主要结局
blood pressure
时间窗: 4 weeks
Baseline and per week after intervention
次要结局
- Fasting blood glucose, fasting insulin, cholesterol, triglycerides, HDL-C and LDL-C(will be measured at 0, 2, 4, 8, 10 and 12 weeks)
- Urinary magnesium, potassium, sodium and creatinine(will be measured at 0, 2, 4, 8, 10 and 12 weeks)