Hypocholesterolemic and Cardioprotective Clinical Evaluation of a Spreadable Cream Prepared With Virgin Olive Oil Enriched in Phytosterols and Bioactive Compounds From Olives in Children and Adolescents
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
- Hypercholesterolemia
研究概览
简要总结
This study aims to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia.
详细描述
A clinical study of nutritional intervention, randomized with double blind, adjusted by randomization blocks that consider age and sex, and crossover of 2 months duration each period, with 1-month washout period, in 50 subjects (25 per randomization group). The study will be carried out in the Reina Sofía Universitary Hospital of Córdoba, as well as at the Institute of Nutrition and Food Technology of the University of Granada.
The effects of the enriched spread in patients on the lipid profile will be evaluated plasma and its action on biomarkers of cardiovascular risk and on the microbiota intestinal depending on the specific genotype of each subject. In addition, the presence of minor olive oil compounds present in plasma (metabolomic analysis). In this way, at the end of the project, scientific information will be available contrasted on the enriched product and its effects on cardiovascular protection, in addition to its palatability and acceptance.
The main objective is to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia.
As specific objectives will be determined:
- To evaluate the effect of the enriched spread on the plasmatic concentrations of total cholesterol, LDLc and other parameters of the lipid profile
- To evaluate the effect of the enriched spread on the oxidative status of LDL plasmatic
- To evaluate the effect of the enriched spread on the antioxidant defense system
- To evaluate the effect of the enriched spread on biomarkers of cardiovascular risk, including inflammatory and endothelial damage markers
- To evaluate the effect of the enriched spread on the intestinal microbiota.
- To evaluate the effect of the enriched spread on the metabolomic changes in plasma.
- To analyze the specific genotype of each volunteer
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
- 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
- •Familial hypercholesterolemia
- •Acceptance to participate by signing the informed consent
排除标准
- •Children under 6 years of age
- •Absence of hypercholesterolemia
- •Children who receive some type of medication to control hypercholesterolemia, blood pressure, levels of glucose or dyslipidemia or any probiotic, which have invalid data for the variables of the present study
- •Not to sign the informed consent.
结局指标
主要结局
Hypercholesterolemia
时间窗: Month 0; Month 2; Month 3; Month 5
Assessing changes of plasma lipids levels from the baseline to the end of each treatment. The serum concentrations of total cholesterol (mg/dL), triglycerides (TG, (mg/dL)), high-density lipoprotein cholesterol (HDLc, (mg/dL)), and low-density lipoprotein cholesterol (LDLc, (mg/dL)), apolipoprotein A1 (Apo-A1, (mg/dL)) and apolipoprotein B (Apo-B, (mg/dL)) will be analyzed by spectrophotometry.
次要结局
- Diastolic blood pressure(Month 0; Month 2; Month 3; Month 5)
- Enzymatic antioxidant status(Month 0; Month 2; Month 3; Month 5)
- Non-enzymatic antioxidant status(Month 0; Month 2; Month 3; Month 5)
- Endothelial function status(Month 0; Month 2; Month 3; Month 5)
- Urine metabolomic analysis(Month 0; Month 2; Month 3; Month 5)
- Body composition percentages(Month 0; Month 2; Month 3; Month 5)
- Body composition(Month 0; Month 2; Month 3; Month 5)
- Systolic blood pressure(Month 0; Month 2; Month 3; Month 5)
- Endothelial damage(Month 0; Month 2; Month 3; Month 5)
- Fecal microbiome(Month 0; Month 2; Month 3; Month 5)
- Oxidation biomarkers(Month 0; Month 2; Month 3; Month 5)
- Plasma metabolomic analysis(Month 0; Month 2; Month 3; Month 5)
研究者
María Dolores Mesa García
Professor
Universidad de Granada