NCT03492983已完成不适用
Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.
Fundacion para la Investigacion y Formacion en Ciencias de la Salud2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of life and cognitive performance.
详细描述
- Objective: To assess the effect at 6 months of the additional intake of 10 g/day of high cocoa content chocolate for 6 months on blood pressure, vascular function, body composition, quality of life and cognitive performance in postmenopausal women.
- Design and setting: A randomized clinical trial of two parallel groups. Population: 140 postmenopausal women, 50 to 64 aged will be included, selected by consecutive sampling in two primary care centers.
- Measurements and intervention: Vascular function (blood pressure, augmentation index and Cardio-Ankle Vascular Index), body composition and health-related quality of life will be evaluated. The intervention group will receive a daily supplement of high cocoa content chocolate for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in postmenopausal period defined as 12 consecutive months of amenorrhea.
排除标准
- •Older than 65 years.
- •Cardiovascular disease (acute myocardial infarction, stroke).
- •Arterial hypertension on treatment.
- •Diabetes mellitus.
- •Dyslipidemia (total cholesterol >250 mg/dL or in lipid-lowering therapy).
- •Clinically demonstrable neurological and/or neuropsychological disorders.
- •Hormone replacement therapy.
- •Allergy and/or intolerance to cocoa or any of the components of the supplement.
- •Hypocaloric diet.
- •Any other circumstance that the investigators consider could interfere with the study procedures.
结局指标
主要结局
Blood pressure
时间窗: 6 months
Measurement by oscillometric method (mmHg)
次要结局
- Arterial stiffness(6 months)
- Wave reflection(6 months)
- Body composition(6 months)
- Quality of life(6 months)
- Cognitive performance(6 months)
研究者
研究点 (2)
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