The Effects of Dark Chocolate Implementation in the Reduction of Oxidative Stress and Improvement of Vascular Function and Physical Performance in Elite Athletes
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
- 否
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
Elena Cavarretta
MD, PhD
University of Roma La Sapienza
