The Effects of Dark Chocolate Implementation in Elite Athletes

Physical Activity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288623
• Other study ID #: CE 4662
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: April 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 1, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletes Heart
• Oxidative Stress
• Physical Activity

Intervention

Dietary Supplement:
• Dark Chocolate (85% cocoa)
Dark chocolate (85% cocoa) in tablet
• White/Milk chocolate (<35% cocoa)
white or milk chocolate (<35% cocoa) in tablet

Locations

Country	Name	City	State
Italy	Sapienza University of Rome, Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 Mu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soluble NOX2-derived peptides (sNOX2-dp)	a marker of nicotinamide adenine dinucleotide phosphateoxidase activation, was detected in serum by ELISA. The peptide was recognised by the speci?c 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 coef?cient of variation is 5%	30 days
Secondary	soluble P-selectin (sPs)	soluble P-selectin levels, a marker of in-vivo platelet activation, will be measured on citrated platelet poor plasma samples by enzyme immunoassay	30 days
Secondary	soluble CD40 Ligands (sCD40L)	soluble CD40 Ligand, a marker of in vivo platelet activation, will be measured using a commercially available method by Luminex Technology according to the manufacturer's instructions (Milliplex Map Kit Millipore, Darmstadt, Germany) in platelet components	30 days
Secondary	Hydrogen Peroxide (H2O2)	Hydrogen peroxide (H2O2) is produced by inflammatory and vascular cells. Extracellular H2O2 is detected using incubation with Amplex Red (10 µM) and horseradish peroxidase (0.2 U/mL) for 60 min at 37 °C in Krebs-Ringer's phosphate glucose buffer (in mM: 145 NaCl, 5.7 sodium phosphate, 4.86 KCl, 0.54 CaCl2, 1.22 MgSO4, and 5.5 glucose) protected from light. Fluorescence is detected at 590 nm using an excitation of 530 nm every 5 min for 60 min. H2O2 is expressed as fluorescence per minute.	30 days
Secondary	flow-mediated dilation (FMD)	Evaluation of brachial artery FMD was performed at 60 seconds (FMD60s) and 120 seconds (FMD120s) postischemic stress by vascular ultrasound. Early FMD was defined as peak FMD60s and delayed FMD as peak FMD120s.	30 days
Secondary	Vitamin E (a-tocopherol, aT)	Serum samples will be supplemented with tocopheryl acetate (internal standard), deproteinized by the addition of ethanol, and extracted with hexane. Phase separation is achieved by centrifugation. The collected upper phase is evaporated and analysed using an Agilent 1200 Infinity series high-performance liquid chromatography system equipped with an Eclipse Plus C18 column (4.6 × 100 mm). Serum levels will be given as the ratio (µmol/mmol) between serum a-tocopherol concentration (µmol/L) and serum total cholesterol concentration (mmol/L), which better express the circulating levels of vitamin E.	30 days
Secondary	Serum isoprostane (8-iso-PGF2a-III)	Serum isoprostane (8-iso-PGF2a-III) is measured by the enzyme immunoassay method (DRG International). The values are expressed as pmol/l.	30 days

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