Clinical trial NCT03288623: The Effects of Dark Chocolate Implementation in Elite Athletes
Official title: The Effects of Dark Chocolate Implementation in the Reduction of Oxidative Stress and Improvement of Vascular Function and Physical Performance in Elite Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Athletes Heart
Physical Activity
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Soluble NOX2-derived peptides (sNOX2-dp)
timeFrame: 30 days
Secondary outcomes:
measure: soluble P-selectin (sPs)
timeFrame: 30 days
measure: soluble CD40 Ligands (sCD40L)
timeFrame: 30 days
measure: Hydrogen Peroxide (H2O2)
timeFrame: 30 days
measure: flow-mediated dilation (FMD)
timeFrame: 30 days
measure: Vitamin E (α-tocopherol, αT)
timeFrame: 30 days
measure: Serum isoprostane (8-iso-PGF2a-III)
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome, Policlinico Umberto I
Study officials:
affiliation: University of Roma La Sapienza
name: Giacomo Frati, MD
role: STUDY_DIRECTOR
References:
citation: Cavarretta E, Peruzzi M, Del Vescovo R, Di Pilla F, Gobbi G, Serdoz A, Ferrara R, Schirone L, Sciarretta S, Nocella C, De Falco E, Schiavon S, Biondi-Zoccai G, Frati G, Carnevale R. Dark Chocolate Intake Positively Modulates Redox Status and Markers of Muscular Damage in Elite Football Athletes: A Randomized Controlled Study. Oxid Med Cell Longev. 2018 Nov 21;2018:4061901. doi: 10.1155/2018/4061901. eCollection 2018.