Antihypertensive and Cardioprotective Clinical Evaluation of a Functional Olive Oil Enriched in Bioactive Compounds From the Olive Tree
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Changes of systolic blood pressure
研究概览
简要总结
The general objective of this study is to evaluate the effect of a nutritional intervention with an extra virgin olive oil (EVOO) rich in bioactive compounds (polyphenols) and a functional oil of adequate organoleptic quality, prepared with the same EVOO rich in polyphenols and also enriched in triterpenic acid compounds from the olive itself, and demonstrate its antihypertensive and cardioprotective effect in children and adolescents (between 6-18 years) at risk of untreated hypertension.
详细描述
A clinical study of nutritional intervention, randomized, adjusted by randomization blocks that consider age and sex, and parallel duration of 6 months, in 75 subjects (25 per randomization group) is proposed. The study will be carried out at the UGC of Pediatrics of the Reina Sofía University Hospital in Córdoba, as well as at the Institute of Nutrition and Food Technology of the University of Granada.
The effects of an optimized oil rich in polyphenols and obtained by mixing varieties rich in said bioactive compounds (approx. 490 ppm), and a functional oil prepared with the same optimized oil and enriched with triterpenic acids obtained from the olive itself (approx. 490 ppm of polyphenols and 380 ppm of triterpenic acids). The study will be carried out in pediatric patients with high levels of untreated blood pressure, in which the effect of oils on blood pressure and their action on biomarkers of cardiovascular risk and on the intestinal microbiota will be evaluated, depending on the genotype specific to each subject. In addition, the presence of minor olive oil compounds present in the plasma will be analyzed (metabolomic analysis). In this way, at the end of the project, verified scientific information will be available on the enriched product and its effects on cardiovascular protection, and on possible mechanisms of action, as well as on its palatability and acceptance.
The general objective of this study is to evaluate the effect of a nutritional intervention with an EVOO rich in bioactive compounds (polyphenols) and a functional oil of adequate organoleptic quality, prepared with the same EVOO rich in polyphenols and also enriched in triterpenic acid compounds from the olive itself, and demonstrate its antihypertensive and cardioprotective effect in children and adolescents (between 6-18 years) at risk of untreated hypertension.
As specific objectives will be determined:
- To evaluate the effect of olive oils on blood pressure levels
- To evaluate the effect of olive oils on the levels of other components of the metabolic syndrome.
- To evaluate the effect of olive oils on the antioxidant defense system
- To evaluate the effect of olive oils on biomarkers of cardiovascular risk, including markers of inflammation and endothelial damage.
- To evaluate the effect of olive oils on the intestinal microbiota.
- To evaluate the effect of olive oils on metabolomic changes in plasma.
- To analyze the specific genotype of each volunteer and its relationship with the clinical effects found.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 18 years Percentile levels compatible with arterial hypertension or very high risk (SBP and/or DBP over P90) Without previous medication for hypertension Acceptance to participate by signing the informed consent
排除标准
- •Children under 6 years of age Absence of hypertension Children who require or receive some type of medication to control blood pressure, glucose levels or dyslipidemia or any probiotic Not to sign the informed consent.
结局指标
主要结局
Changes of systolic blood pressure
时间窗: 0 month; 3 month; 6 month
Changes on systolic blood pressure will be measured at the beginning, 3 and 6 months after the intervention. It will be measured in a sitting position and after 5 minutes of rest, using an OMRON HEM 705 CP device, with the cuff adapted to each child, on the left arm. Systolic and diastolic blood pressure will be measured in duplicate, and the mean of both measurements will be recorded, in millimeters of mercury.
Change from Baseline Diastolic Blood Pressure at 6 months
时间窗: 0 month; 3 month; 6 month
Changes on systolic and diastolic blood pressure will be measured at the beginning, 3 and 6 months after the intervention. It will be measured in a sitting position and after 5 minutes of rest, using an OMRON HEM 705 CP device, with the cuff adapted to each child, on the left arm. Systolic and diastolic blood pressure will be measured in duplicate, and the mean of both measurements will be recorded, in millimeters of mercury.
次要结局
- Sedentary activities(0 month; 3 month; 6 month)
- Change of body composition from Baseline to 6 months(0 month; 3 month; 6 month)
- Hemogram(0 month; 3 month; 6 month)
- Blood insulin(0 month; 3 month; 6 month)
- Serum cholesterol(0 month; 3 month; 6 month)
- Endothelial function biomarkers in blood(0 month; 3 month; 6 month)
- Antioxidant glutathione reductase activity in red blood cells(0 month; 3 month; 6 month)
- Change n weight from baseline to 6 months(0 month; 3 month; 6 month)
- Change on body mass index (BMI) from Baseline to 6 months(0 month; 3 month; 6 month)
- Dietary intake and eating habits(0 month; 3 month; 6 month)
- Physical activity(0 month; 3 month; 6 month)
- Blood glucose(0 month; 3 month; 6 month)
- Serum triacylglycerides(0 month; 3 month; 6 month)
- Antioxidant glutathione peroxidase activity in red blood cells(0 month; 3 month; 6 month)
- Antioxidant catalase activity in red blood cells(0 month; 3 month; 6 month)
- Metagenomics(0 month; 6 month)
- Urine endothelin-1(0 month; 3 month; 6 month)
- F2-Isoprostanes in urine(0 month; 3 month; 6 month)
- 8-hydroxy-deoxy-Guanosine in urine(0 month; 3 month; 6 month)
- Genotyping(0 month)
- Antioxidant superoxide dismutase activity in red blood cells(0 month; 3 month; 6 month)
- Insulin resistance(0 month; 3 month; 6 month)
- Plasma metabolomic analysis(0 month; 6 month)
- Urine metabolomic analysis(0 month; 3 month; 6 month)
- Antioxidant alpha-tocopherol, beta-carotene, retinol and Coenzyme Q in plasma(0 month; 3 month; 6 month)
- Analysis of oxLDL in plasma(0 month; 3 month; 6 month)
研究者
María Dolores Mesa García
Professor
Universidad de Granada