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The Effects of Dark Chocolate Implementation in Elite Athletes

U

University of Roma La Sapienza

Status

Completed

Conditions

Physical Activity
Athletes Heart
Oxidative Stress

Treatments

Dietary Supplement: Dark Chocolate (85% cocoa)
Dietary Supplement: White/Milk chocolate (<35% cocoa)

Study type

Interventional

Funder types

Other

Identifiers

NCT03288623
CE 4662

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

Dark Chocolate
Experimental group
Description:
Dark chocolate (85% cocoa) 40 mg per day for 30 days
Treatment:
Dietary Supplement: Dark Chocolate (85% cocoa)
White/Milk Chocolate
Placebo Comparator group
Description:
White chocolate or Milk chocolate administration in tablet (\<35% cocoa) per day for 30 days
Treatment:
Dietary Supplement: White/Milk chocolate (<35% cocoa)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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