Effect of the Combination of Polyphenols Derived From the Hibiscus Sabdariffa and Lippia Citriodora on Slightly Hypertensive or Type 1 Hypertensive Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Changes in Blood Pressure Measurement with respect to baseline
研究概览
简要总结
Determine if a double-blind, randomized, placebo-controlled clinical intervention, based on a dietetic intervention and physical exercise, supplemented with a polyphenolic extract, decreases blood pressure in hypertensive volunteers.
详细描述
Slightly hypertensive individuals, before diagnosed with type 1 hypertension, are generally monitored by their physician and given dietetic and physical activity guidelines. The objective of this intervention is to prevent onset of a hypertensive pathologic condition. However, in many cases, this intervention is unsuccessful, and therefore the patient must follow-up with anti-hypertensive drugs.
Here, in the current study, the objective is to include a nutritional supplement in the intervention in order to increase the probability of success of the diet/exercise intervention. Previous studies with the supplement Metabolaid has shown the product to significantly decrease the blood pressure of slightly hypertensive individuals. It is estimated, based on the results of previous clinical studies, that the polyphenolic content of the nutritional supplement will reduce at least an additional 10% of the blood pressure of the patients undergoing a diet and exercise intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Slight or type 1 hypertension with no pharmacological treatment, but with annual controls of the blood pressure
排除标准
- •Minors (under 18 years of age)
- •volunteers with high cardiovascular disease risk
- •pharmacological treatment for blood pressure
- •presence of any chronic disease/condition
- •known allergies regarding the supplement and/or placebo
结局指标
主要结局
Changes in Blood Pressure Measurement with respect to baseline
时间窗: One measurement per day, 1 day per week, total 6 weeks
Single Blood Pressure measurements, using the Omron M6 Comfort device
次要结局
- Total Cholesterol(At the beginning and end of the intervention, total 6 weeks)
- HDL Cholesterol(At the beginning and end of the intervention, total 6 weeks)
- LDL Cholesterol(At the beginning and end of the intervention, total 6 weeks)
- Triglycerides(At the beginning and end of the intervention, total 6 weeks)
- Glucose(At the beginning and end of the intervention, total 6 weeks)
- Weight, using a weight scale(Once a week, for 6 weeks)
- Height, using measuring tape(Once a week, for 6 weeks)
- BMI, calculated based on Weight and Height(Once a week, for 6 weeks)
- Waist Circumference, using a measuring tape(Once a week, for 6 weeks)
- Hip Circumference, using a measuring tape(Once a week, for 6 weeks)
- Waist/Hip Ratio(Once a week, for 6 weeks)
- Physical Activity Assessment using the Stanford 7-days physical activity recall questionnaire(At baseline, 3 and 6 weeks)
研究者
María Herranz-Lopez
Assistant Professor
Universidad Miguel Hernandez de Elche