The Effects of California Strawberries on Parameters of Cardiovascular Health
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Vascular function measured by peripheral arterial tonometry
研究概览
简要总结
The prevalence of childhood obesity has been increasing over the past couple of decades. Similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and Type 2 diabetes. Epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. Strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. A number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. We hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects, age 14 - 18 years.
- •BMI for age and gender >75th percentile (based on CDC growth charts)
- •Subject is willing and able to comply with the study protocols.
排除标准
- •Inability to wear PAT probes
- •Inability to remain still and remain quiet during test procedures
- •BMI for age and gender ≤ 75th percentile (based on CDC growth charts)
- •The use of medications that affect vascular function
- •Regular use of dietary supplements during the last 6 months
- •Blood pressure for age, gender and height ≥95th percentile
- •Chronic/routine high intensity exercise or current participation in a sports program
- •Self/Parent reported use of anticoagulation agents including NSAIDs
- •Self/Parent reported use of oral cortisone or other immunosuppressive agents,
- •Self/Parent reported underlying neoplasia or immunological disease
- •Self/Parent reported diabetes
- •Food faddists or those taking a non-traditional diet
- •Allergies to fruit
- •Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference
- •range) if determined to be clinically significant by the study physician.
- •Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas).
- •Asthma (can be worsened by mild to moderate food allergies).
研究组 & 干预措施
Flavonoid-rich freeze-dried strawberry powder
50g of flavonoid-rich freeze-dried strawberry powder
干预措施: flavonoid-rich freeze-dried strawberry powder (Dietary Supplement)
macronutrient- matched control powder
50g macronutrient-matched control powder that will lack strawberry flavonoids
干预措施: macronutrient-matched control powder (Dietary Supplement)
结局指标
主要结局
Vascular function measured by peripheral arterial tonometry
时间窗: Change from baseline in vascular function at 1 hour and 1 week
Change from baseline at 1 hour and 1 week post consumption of freeze-dried strawberry powder or control powder
次要结局
未报告次要终点