Effect of a French Maritim Pine Bark Extract Oligopin® on Blood Pressure: Double Blind, Crossover, Placebo-controlled Nutrition Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Differences detected on the time evolution of BP both in two arms of intervention
研究概览
简要总结
The objective of the study is to evaluate the effect of consumption of a food supplement rich in procyanidins extracted from the bark of French pine, Oligopin®, on blood pressure of people with mild / moderate degree of hypertension. Furthermore, the effect Oligopin® consumption on markers involved in the development of hypertension, and endothelial function in key enzymes that regulate blood pressure, inflammation and oxidation are considered. Also, try to advance the understanding of the molecular mechanisms that regulate blood pressure.
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
- Quadruple (Participant, Care Provider, 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
- •early stages of hypertension (systolic BP ≥ 140 and ≤ 159 mm Hg) and/or diastolic BP: ≥ 90 and ≤ 99 mm Hg
- •not receiving BP-lowering medication.
- •obtained written informed consent before the initial screening visit.
排除标准
- •Body Mass Index (BMI) > 30 kg/m2
- •taking antihypertensive medications
- •pregnant or who intends to become pregnant
- •wife in breastfeeding period
- •persons with a self-reported history of clinical cardiovascular disease, cancer, chronic kidney disease (or a serum creatinine ≥ 1.7 mg/dL for men and ≥ 1.5 mg/dL for women) hypercholesterolemia (LDL-c ≤ 189 mg/dL, diabetes mellitus (or serum glucose ≥126 mg/dL), or consumption of more than 14 drinks of alcoholic beverages per week.
研究组 & 干预措施
Product one
150 mg (maltodextrin)/day (75 mg maltodextrin included in 280 mg/gelule; 2 times/day: morning and evening) of Placebo plus Dietary Approaches to Stop Hypertension (DASH)
干预措施: Placebo (Dietary Supplement)
Product two
150 mg Oligopin/day (75mg Oligopin included in 280mg/gelule; 2 times/day: morning and evening) of Oligopin® plus Dietary Approaches to Stop Hypertension (DASH)
干预措施: Oligopin® (Dietary Supplement)
结局指标
主要结局
Differences detected on the time evolution of BP both in two arms of intervention
时间窗: 5 weeks
次要结局
- - Biomarker related with inflammatory processes (High sensitive C Reactive Protein) - Biomarkers of antioxidant system (Oxidised- LDL levels, Reduced glutathione, Oxidised glutathione, Ratio Glutathione balance)(Weeks 2, 5, 6, 9)
- Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT)(Week 1)
- Anthropometric data (Weight, BMI, Waist circumference)(weeks 2, 5, 6, 9)
- Endothelial function (Laser-Doppler)(Weeks 2, 5, 6, 9)
- - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity)(Weeks 2, 5, 6, 9)