Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
研究概览
简要总结
An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). Hence a personalized categorical food avoidance diet averts relapse and maintains remission of psoriasis, with side benefit on blood pressure and other metabolic parameters (J Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would improve the control of essential hypertension. A randomized controlled clinical trial is proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40 study participants will be randomly assigned to either conventional or interventional dietary counselling. They will be comprehensively monitored (including gene expression studies) for two years. Outcome criteria will include blood pressure, complications of hypertension, side-benefit on comorbidity, and requirement for antihypertensive drugs.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •average blood pressure exceeds 160/100mm Hg (140/90 if additional vascular risk), regardless of whether on treatment
- •on one or two antihypertensive drugs AND average BP exceeds 140/90 (130/80 if additional risk)
- •on three or more antihypertensives, regardless of whether BP controlled
- •sufficiently literate to follow detailed dietary instructions
- •informed consent
排除标准
- •disabling complications of hypertension
- •secondary cause of hypertension
- •age less than 18 years
结局指标
主要结局
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
时间窗: 2 years
次要结局
- serious (disabling) adverse events attributable to hypertension or its drug treatment(2 years)
- resolution of hypertension (normal blood pressure, no drugs required)(2 years)
研究者
Dr C.P. Chijioke
Professor C.P. Chijioke
University of Nigeria, Enugu Campus
