An interventional study of Dark Chocolate (85% cocoa) and White/Milk chocolate (<35% cocoa) in Oxidative Stress, Athletes Heart and Physical Activity, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to male participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
Among 186 studies in Motor Activity with a site in Italy — 62 open to participants now, 72 under way, none of them phase 3. Motor Activity · Italy.
Among the 186 studies in Motor Activity with a site in Italy, this one is the 124th largest by enrollment of the 143 interventional ones that give a count, is one of 10 that started in 2017, is one of 130 with no phase, and was the 40th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →62 of the 186 studies in Motor Activity with a site in Italy are open now. Recruiting first, the newest first:
Catholic University, Italy · Sites in Italy
University of Pavia · Sites in Italy
University of Bergamo · Sites in Italy
University of Milan · Sites in Italy
IRCCS Centro San Giovanni di Dio Fatebenefratelli · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 18 Years to 35 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
186 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 10 started in 2017.
This study's enrollment of 24 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 100 across the 143 interventional studies, 180 across the 43 observational. Of the 88 that completed or were terminated, 3 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 186 have an industry lead sponsor. The 10 most frequent:
University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
University of Roma La Sapienza has 6 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
13 of the studies in Motor Activity with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06783387Centro Universitario Ricerca Interdipartimentale Attivita' MotoriaPhysical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach | 2026-12-15 |
| NCT06884631Centro Cardiologico MonzinoMetabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure | 2026-12-31 |
| NCT05934084Fondazione Italiana Linfomi - ETSLifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors | 2027-02-01 |
| NCT03799354Istituti Clinici Scientifici Maugeri SpAStudy on Impact of Maximal Strength Training in Patients With COPD | 2027-02-28 |
| NCT05708443Istituti Clinici Scientifici Maugeri SpAEffect of Combined Endurance Training on ADL and Walking in COPD Patients | 2027-02-28 |
Among the 186 studies in Motor Activity with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dark chocolate (85% cocoa) 40 mg per day for 30 days
Dietary Supplement: Dark Chocolate (85% cocoa)
White chocolate or Milk chocolate administration in tablet (\<35% cocoa) per day for 30 days
Dietary Supplement: White/Milk chocolate (<35% cocoa)
Dark chocolate (85% cocoa) in tablet
white or milk chocolate (\<35% cocoa) in tablet
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%
Time frame: 30 days
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
Plan to share: Undecided — De-identified individual participant data for all primary and secondary outcome measures will be made available
Ran from Sep 2017 to primary completion in Mar 2018, 6 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 6 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cocoa bean
University of Roma La Sapienza →