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临床试验/NCT03288623
NCT03288623已完成不适用

The Effects of Dark Chocolate Implementation in the Reduction of Oxidative Stress and Improvement of Vascular Function and Physical Performance in Elite Athletes

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Soluble NOX2-derived peptides (sNOX2-dp)

研究概览

简要总结

Dark chocolate (DC) is rich in epicatechin which augments nitric oxide (NO) production through endothelium-dependent influences. The increased bioavailability and activity of NO have been demonstrated to statistically increase flow-mediated dilation in healthy subjects and in hypertensive patients. DC supplementation has been hailed for its positive effects on cardiovascular health and it has been proposed as a booster of physical performance in athletes, however the mechanisms by which DC improves oxidative stress, vascular function and athletic performance are not fully understood. The investigators designed a human study assessing how DC improves NO bioavailability and activity in elite athletes. Twenty-four elite soccer players (aged 18-35 years old, all males) are divided in 2 groups and randomly assigned to receive DC (85% cocoa), 40g per day or white/milk chocolate (<35% cocoa) for 30 days. The primary outcome measure is the evaluation of Soluble NOX2-derived peptide (sNOX2-dp), a direct marker of NADPH oxidase activation. The secondary outcome measures are other markers of oxidative stress, as the soluble P-selectin (sPs), Vitamin E, soluble CD40 Ligand (sCD40L), a marker of in vivo platelet activation and flow-mediated dilation assessed by vascular ultrasound. All parameters are assessed at baseline and after 30 days in both groups.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Elite male athletes volunteers, aged between 18 and 35 years

排除标准

  • they suffer from an allergy to cocoa or any of the ingredients contained within either of the chocolate bars
  • they have a low platelet count (< 170 x 10E09/ L)
  • they are taking aspirin or aspirin-containing drugs, other anti-inflammatory drugs, or any drugs or herbal medicines known to alter platelet function or the haemostatic system in general (without a minimum washout period of one month)
  • they are taking fish oils or evening primrose oil, or fat soluble vitamin supplements within the last 4 weeks
  • they have unsuitable veins for blood sampling and/ or cannulation
  • they have a BMI below 18 or above 35 kg/ sqm
  • they are taking any medicine known to affect lipid and/or glucose metabolism
  • they are suffering from alcohol or any other substance abuse or are having eating disorders
  • they have any known clinical signs of diabetes, hypertension, renal, hepatic, hematological disease, gastrointestinal disorders, endocrine disorders, coronary heart disease, infection or cance

结局指标

主要结局

Soluble NOX2-derived peptides (sNOX2-dp)

时间窗: 30 days

a marker of nicotinamide adenine dinucleotide phosphateoxidase activation, was detected in serum by ELISA. The peptide was recognised by the specific monoclonal antibody against the amino-acidic sequence (224-268) of the extra membrane portion of NOX2. Values were expressed as pg/mL; intra-assay and inter-assay coefficient of variation is 5%

次要结局

  • soluble CD40 Ligands (sCD40L)(30 days)
  • Hydrogen Peroxide (H2O2)(30 days)
  • soluble P-selectin (sPs)(30 days)
  • Vitamin E (α-tocopherol, αT)(30 days)
  • Serum isoprostane (8-iso-PGF2a-III)(30 days)
  • flow-mediated dilation (FMD)(30 days)

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

Elena Cavarretta

MD, PhD

University of Roma La Sapienza

研究点 (2)

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