- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288623
The Effects of Dark Chocolate Implementation in Elite Athletes
April 15, 2019 updated by: Elena Cavarretta, University of Roma La Sapienza
The Effects of Dark Chocolate Implementation in the Reduction of Oxidative Stress and Improvement of Vascular Function and Physical Performance in Elite Athletes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00161
- Sapienza University of Rome, Policlinico Umberto I
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dark Chocolate
Dark chocolate (85% cocoa) 40 mg per day for 30 days
|
Dark chocolate (85% cocoa) in tablet
|
Placebo Comparator: White/Milk Chocolate
White chocolate or Milk chocolate administration in tablet (<35% cocoa) per day for 30 days
|
white or milk chocolate (<35% cocoa) in tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Soluble NOX2-derived peptides (sNOX2-dp)
Time Frame: 30 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
soluble P-selectin (sPs)
Time Frame: 30 days
|
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
|
soluble CD40 Ligands (sCD40L)
Time Frame: 30 days
|
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
|
Hydrogen Peroxide (H2O2)
Time Frame: 30 days
|
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
|
flow-mediated dilation (FMD)
Time Frame: 30 days
|
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
|
Vitamin E (α-tocopherol, αT)
Time Frame: 30 days
|
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 α-tocopherol concentration (μmol/L) and serum total cholesterol concentration (mmol/L), which better express the circulating levels of vitamin E.
|
30 days
|
Serum isoprostane (8-iso-PGF2a-III)
Time Frame: 30 days
|
Serum isoprostane (8-iso-PGF2a-III) is measured by the enzyme immunoassay method (DRG International).
The values are expressed as pmol/l.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Giacomo Frati, MD, University of Roma La Sapienza
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2017
Primary Completion (Actual)
March 31, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
September 14, 2017
First Submitted That Met QC Criteria
September 18, 2017
First Posted (Actual)
September 20, 2017
Study Record Updates
Last Update Posted (Actual)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CE 4662
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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