The Effects of Dark Chocolate Implementation in the Reduction of Oxidative Stress and Improvement of Vascular Function and Physical Performance in Elite Athletes
| Registry | NCT03288623 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 24 (Actual) |
| Sponsor | University of Roma La Sapienza (Other) |
| Conditions | Oxidative Stress, Athletes Heart, Physical Activity |
| Interventions | Dark Chocolate (85% cocoa), White/Milk chocolate (<35% cocoa) (Dietary supplement) |
| Dates | start 2017-09-25, primary completion 2018-03-31, completion 2018-11-01, first posted 2017-09-20, last updated 2019-04-17 |
| Locations | 1 site in Italy |
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All trials for Oxidative Stress All trials for Athletes Heart All trials of Dark Chocolate (85% cocoa) All trials of White/Milk chocolate (<35% cocoa)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dark Chocolate | Experimental | Dietary Supplement: Dark Chocolate (85% cocoa) | Dark chocolate (85% cocoa) 40 mg per day for 30 days |
| White/Milk Chocolate | Placebo comparator | Dietary Supplement: White/Milk chocolate (<35% cocoa) | White chocolate or Milk chocolate administration in tablet (<35% cocoa) per day for 30 days |
Sex: Male, ages: 18 Years to 35 Years
Inclusion Criteria: * Elite male athletes volunteers, aged between 18 and 35 years Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Sapienza University of Rome, Policlinico Umberto I | Rome | Italy |