Natural Antioxidant Ice-cream Acutely Reduces Oxidative Stress, Improves Vascular Function and Physical Performance in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Endothelial function
研究概览
简要总结
Formation of reactive oxygen species (ROS) contributes to pathogenesis and progression of several diseases. Polyphenols, have been shown to be beneficial against ROS.
This study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on oxidative stress, vascular function and physical performance. In this controlled, single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or milk chocolate ice-cream (control ice-cream). Subjects were studied at baseline and two hours after the ingestion of the ice-creams. Serum polyphenols, antioxidant status (ferric reducing ability of plasma, FRAP), NO bioavailability (NOx), markers of oxidative stress (D-Roms and H2O2), endothelium function (FMD and RHI) and exercise tolerance (Stress Test) with measurement of the double product were assessed.
详细描述
14 healthy, non-smoking, volunteers (7 males ), aged between 20 and 40 years were enrolled. The study was randomized, placebo-controlled. After enrollment, 3 days before entering the study, all subjects performed an exercise stress test. They were then randomly allocated to the treatment sequence with 100 mg of natural anti-oxidant ice cream or milk chocolate ice-cream (control icecream) in a cross-over single-blind design. There was 1 week wash-out between 2 phases of the study.
Markers of oxidative stress (D-ROMs and H2O2); serum antioxidant status (FRAP), NO bioavailability (NOx), the endothelium flow-mediated vasodilation (FMD and the RHI by Endopat 2000) were evaluated in fasting condition at baseline (time 0) and 2 hours after the ingestion of the anti-oxidant or control ice-creams. The exercise stress test was performed before randomization and 2 hours after each ice-cream meal test. In both experiments, the ice-cream was consumed within 10 min.
Each subject was asked to refrain from any kind of medication, diet integrators, intensive physical activity and to avoid consumption of polyphenols rich foods, such cocoa-containing products, red wine, tea within the previously 2 weeks. All participants gave written informed consent, and the study was approved by the Medical Ethics Committee of La Sapienza University of Rome (Rif: 3727, Prot: 2325/15).
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, non-smoking, volunteers
排除标准
- •Assumption of any kind of medication, diet integrators, intensive physical activity and to avoid consumption of polyphenols rich foods, tea within the previously 2 weeks.
研究组 & 干预措施
Antioxidant Ice-cream
Natural antioxidant Ice-cream
干预措施: Antioxidant ice-cream (Other)
Control Ice-cream
Natural control ice-cream
干预措施: Control Ice-cream (Other)
结局指标
主要结局
Endothelial function
时间窗: Acute 2 hours
Endothelial function will be performed By Endopat2000 and FMD
次要结局
未报告次要终点
研究者
Davide Francomano
PhD Researcher
University of Roma La Sapienza
