The Effects of Dark Chocolate Implementation in Elite Athletes

NCT03288623 | Completed DMC

• 1 other identifier: CE 4662
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Athletes Heart; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 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%

  30 days

Secondary Outcomes (6)

• soluble P-selectin (sPs)

  30 days

• soluble CD40 Ligands (sCD40L)

  30 days

• Hydrogen Peroxide (H2O2)

  30 days

• flow-mediated dilation (FMD)

  30 days

• Vitamin E (α-tocopherol, αT)

  30 days

Study Arms (2)

Dark Chocolate

EXPERIMENTAL

Dark chocolate (85% cocoa) 40 mg per day for 30 days

Dietary Supplement: Dark Chocolate (85% cocoa)

White/Milk Chocolate

PLACEBO COMPARATOR

White chocolate or Milk chocolate administration in tablet (\<35% cocoa) per day for 30 days

Dietary Supplement: White/Milk chocolate (<35% cocoa)

Interventions

Dark Chocolate (85% cocoa) DIETARY_SUPPLEMENT

Dark chocolate (85% cocoa) in tablet

Dark Chocolate

White/Milk chocolate (<35% cocoa) DIETARY_SUPPLEMENT

white or milk chocolate (\<35% cocoa) in tablet

White/Milk Chocolate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome, Policlinico Umberto I

Rome, 00161, Italy

Location

Related 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 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.

  PMID: 30584461 RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Giacomo Frati, MD

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 20, 2017
• Study Start: September 25, 2017
• Primary Completion: March 31, 2018
• Study Completion: November 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

IT (1)