Cardiovascular Effects of Pine Bark Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
研究概览
简要总结
The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile.
详细描述
Cardiovascular disease is the number one cause of death in the Unites States. Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors. We are conducting a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, among 130 study participants. These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease (CVD) because of having prehypertension, excess body weight, and insulin insensitivity. We aim to determine (in order of priority):
- The efficacy of Flavangenol in lowering blood pressure.
- The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
- Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
- The safety of Flavangenol, as confirmation of past studies.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systolic blood pressure between 125 and 159 mmHg and diastolic blood pressure (DBP) < 100 mmHg
- •Body mass index (BMI) 25.0-34.9
- •Triglycerides (TG) < 450 mg/dL
- •Low Density Lipoprotein (LDL) < 200 mg/dL
- •Fasting blood glucose (FBG) < 126 mg/dL
排除标准
- •DBP > 95 mmHg
- •LDL > 170 mg/dL
- •TG > 300 mg/dL
- •FBG > 110 mg/dL
研究组 & 干预措施
Placebo
Placebo delivered as four tablets matching the active product once daily orally.
干预措施: Pine Bark Extract (Flavangenol®) (Drug)
Pine Bark Extract
Flavangenol 200 mg Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day.
干预措施: Pine Bark Extract (Flavangenol®) (Drug)
结局指标
主要结局
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
时间窗: three months
Mean at Week 12 observation minus mean at Baseline observation.
次要结局
- ALT/SGPT(three months)
- AST/SGOT(three months)
- Triglycerides(three months)
- LDL Particle Size(3 months)
- HDL Particle Size(3 months)
- Lipoprotein A(three months)
- C-reactive Protein(three months)
- Body Mass Index(three months)
- Weight(3 months)
- Fasting Blood Glucose(three months)
- Fasting Insulin(three months)
- Hemoglobin A1c(three months)
- Total Cholesterol(3 months)
- LDL(3 months)
- HDL(3 months)
研究者
Randall Stafford
Professor of Medicine
Stanford University