The Effects of Dark Chocolate Implementation in Elite Athletes

NCT ID: NCT03288623

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2018-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dark Chocolate

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

Group Type: EXPERIMENTAL

Dark Chocolate (85% cocoa)

Intervention Type: DIETARY_SUPPLEMENT

Dark chocolate (85% cocoa) in tablet

White/Milk Chocolate

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

Group Type: PLACEBO_COMPARATOR

White/Milk chocolate (<35% cocoa)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Dark Chocolate (85% cocoa)

Dark chocolate (85% cocoa) in tablet

Intervention Type: DIETARY_SUPPLEMENT

White/Milk chocolate (<35% cocoa)

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Elena Cavarretta

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giacomo Frati, MD

Role: STUDY_DIRECTOR

University of Roma La Sapienza

Locations

Sapienza University of Rome, Policlinico Umberto I

Rome, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 30584461 (View on PubMed)

Other Identifiers

CE 4662

Identifier Type: -

Identifier Source: org_study_id