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临床试验/NCT02685163
NCT02685163已完成不适用

Natural Antioxidant Ice-cream Acutely Reduces Oxidative Stress, Improves Vascular Function and Physical Performance in Healthy Subjects

University of Roma La Sapienza0 个研究点目标入组 14 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

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

Experimental

Natural antioxidant Ice-cream

干预措施: Antioxidant ice-cream (Other)

Control Ice-cream

Placebo Comparator

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Francomano

PhD Researcher

University of Roma La Sapienza

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