Oxidative StressNCT03288623
The Effects of Dark Chocolate Implementation in Elite Athletes
A study testing Dark Chocolate (85% cocoa) and White/Milk chocolate (<35% cocoa) in people with Oxidative Stress and Athletes Heart, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Oxidative Stress, Athletes Heart, Physical Activity
- What is being tested?
- Dark Chocolate (85% cocoa) and White/Milk chocolate (<35% cocoa)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Elite male athletes volunteers, aged between 18 and 35 years
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Dark Chocolate (85% cocoa), White/Milk chocolate (<35% cocoa)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark Chocolate (85% cocoa)Dietary supplement
Dark chocolate (85% cocoa) in tablet
White/Milk chocolate (<35% cocoa)Dietary supplement
white or milk chocolate (<35% cocoa) in tablet
| Study group | Role | What they receive |
|---|---|---|
| Dark Chocolate | Experimental | Dark chocolate (85% cocoa) 40 mg per day for 30 days Receives: 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 Receives: Dietary Supplement: White/Milk chocolate (<35% cocoa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 30 days
Secondary outcomes (6)
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
Measured: 30 days
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
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Vitamin E (α-tocopherol, αT)
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start25 Sep 2017
- Primary completion31 Mar 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cavarretta, University of Roma La Sapienza
- Investigators
- Giacomo Frati, MD, Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288623
- Sponsor's protocol ID
- CE 4662
- Status last verified
- Apr 2019
- First submitted
- 14 Sep 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 30584461
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03288623
- Acronym / sponsor ID
- CE 4662
- Conditions
- Oxidative Stress, Athletes Heart, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dark Chocolate | Experimental | Dietary Supplement: Dark Chocolate (85% cocoa)Dark chocolate (85% cocoa) 40 mg per day for 30 days |
| White/Milk Chocolate | Placebo comparator | Dietary Supplement: White/Milk chocolate (<35% cocoa)White chocolate or Milk chocolate administration in tablet (<35% cocoa) per day for 30 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elite male athletes volunteers, aged between 18 and 35 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark Chocolate (85% cocoa)Dark chocolate (85% cocoa) in tablet | Dietary supplement | Dark Chocolate |
| White/Milk chocolate (<35% cocoa)white or milk chocolate (<35% cocoa) in tablet | Dietary supplement | White/Milk Chocolate |
Primary outcome
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%
6 secondary outcomes
soluble P-selectin (sPs)
Time frame: 30 days
soluble CD40 Ligands (sCD40L)
Time frame: 30 days
Hydrogen Peroxide (H2O2)
Time frame: 30 days
flow-mediated dilation (FMD)
Time frame: 30 days
Vitamin E (α-tocopherol, αT)
Time frame: 30 days
Serum isoprostane (8-iso-PGF2a-III)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Results publication: PubMed 30584461Cavarretta 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.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Frati, MD study director
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark Chocolate (85% cocoa) and White/Milk chocolate (<35% cocoa) in people with Oxidative Stress and Athletes Heart, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soluble NOX2-derived peptides (sNOX2-dp) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.