Effects of Punicalagin and Hydroxytyrosol Mixture on Different Inflammatory Markers Related With Cardiovascular Disease: a Crossover Study in Healthy Middle-aged Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in the Inflammatory markers after 8 weeks treatment
研究概览
简要总结
A crossover trial was carried out in healthy volunteers aged 45-70 years and BMI <30 kg/m2. Subjects consumed a Antioxidant Supplement (AS) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a Control Supplement (CS) with maltodextrin for an 8 wk each phase with 4-wk rest period. Supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. The endothelial function parameters (brachial artery flow-mediated dilation (FMD), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. Previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of Functional Supplement.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women from 45 to 75 years old;
- •Signed informed consent
排除标准
- •Individuals with cardiovascular risk factors on drug treatment (dyslipidemia, hypertension, Diabetes Mellitus);
- •Individuals with Metabolic Syndrome;
- •Individuals with familiar background of premature cardiovascular disease;
- •Individuals with BMI ≥ 30 kg/m2;
- •Women that still maintain your menstrual cycle;
- •Individuals with increased alcohol consumption 30g/day;
- •Individuals that stop smoking in the next 20 weeks (during the study);
- •Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics;
- •Women that consume oral contraceptive;
- •Individuals with mental disease or low cognitive function;
- •Individuals with severe diseases (hepatic, kidney, cancer...);
- •Individuals with drugs or supplements consumption to weight lost;
- •Pregnant women or lactating;
- •Individuals with intensive physical activity;
- •Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
结局指标
主要结局
Change in the Inflammatory markers after 8 weeks treatment
时间窗: 0, 8, 12 and 20 weeks
Inflammatory markers (Fibrinogen, gelsolin, thrombospondin, interleukin 6 and PCR) will be measured at week 0 and 8 for phase I, and at week 12 and 20 for phase II
次要结局
- Change in Glucose Metabolism(0, 8, 12 and 20 weeks)
- Change in Endothelial function(0, 8, 12 and 20 weeks)
- Change in Coagulation markers(0, 8, 12 and 20 weeks)
- Change in Oxidative Stress Parameters(0, 8, 12 and 20 weeks)
- Change in Lipid profile(0, 8, 12 and 20 weeks)
- Change in Anthropometric and body composition parameters(0, 8, 12 and 20 weeks)
- Adverse effects(0 to 20 weeks)
- Adherence and Tolerance Parameters(0 to 20 weeks)