Non-professional triathlon Other
Conditions
Interventions
This will be an open-label, prospective, randomized, crossover pilot study on effects of NOBEET juice supplementation on markers of oxidative stress and inflammation in male subjects practicing non-co
Sponsors
Gensan s.r.l.
Eligibility
Sex/Gender
Male
Age
30 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Written voluntary informed consent to participate in the study 2. Male subjects aged 30-59 years (inclusive) 3. Subjects practicing non-competitive triathlon (competitive triathlon may have been practiced in the past up to the age of 20 years) 4. Subjects regularly performing weekly training for at least 300 minutes 5. Subjects with good physical health as determined by medical and surgical history, physical examination 6. Subjects having received a still valid medical certification for suitability to practice agonistic sports 7. Normal blood pressure (systolic blood pressure [SBP] =90, =140 mmHg; diastolic blood pressure [DBP] =50, =90 mmHg) measured after 5 min rest in supine position 8. A pulse rate at rest of =40 and =90 beats/min measured after 5 min rest in supine position 9. Subjects able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement
Exclusion criteria
Exclusion criteria: 1. Subjects having participate in any race in the past 4 weeks 2. Subjects demonstrating excess in xanthine consumption (more than 5 cups or 1 l of coffee or equivalent per day) 3. Subjects having history of alcohol abuse or drug addiction, or more than moderate actual alcohol consumers 4. Current heavy smokers (former heavy smokers have to have stopped smoking at least 6 months before entry into the study). 5. Use of any medication (self-medication or prescription medication) or non-pharmaceutical products (e.g., food supplements) within 14 days before entry in the study (or at least 5 times the respective elimination half-life, whichever is longer) (exception: a single dose of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) is permitted, provided that it is not taken in the previous 48 hours) 6. Any vaccination within 4 weeks before entry in the study 7. Subjects with any active physical disease, acute or chronic 8. Subjects with current or history of any allergies or hypersensitivity reactions, especially with cutaneous manifestation, asthma, urticaria or other severe allergic diathesis as well as current hay fever 9. Subjects with any history of hypersensitivity to the product under study or its excipients 10. Subjects with any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (especially history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, or myopathies 11. Subjects with any central nervous system (CNS)-related, neurological or psychiatric ailments, psychological disturbances, mental restrictions 12. Clinically relevant findings in the physical examination or/and in the cardiopulmonary ultrasound performed at the screening visit 13. Blood donation or plasmapheresis within 4 weeks before entry in the study 14. Any participants who are not able / willing to understand the Informed Consent Form to the study based on their own decision 15. Concomitant participation in another study or participation in the evaluation of any investigational drugs/devices during 3 months before this study or previous participation in the present study 16. The participation in the study is also not permitted to employees of the investigational site with direct involvement in the study or in other studies under the direction of that Investigator, as well as family members of the employees or the Investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Oxidative stress, i.e. the ROS H2O2 and O2·-, as measured by means of EPR at the end of the 15-day washout period (Visit 3: Day 22) 2. Parameters of the NO pathway (i.e., blood-inducible nitric oxide synthase [iNOS], blood and urinary nitrogen oxides [NOx], blood 3-nitrotyrosine [3-NT], blood peroxynitrite), after about 2 hours from the first administration of the product under study, following the 7 days of administration of the product under study (Visit 2: Day 7, and Visit 4: Day 28), and at the end of the 15-day washout period (Visit 3: Day 22) 3. Markers of lipidic peroxidation (i.e. blood and urinary 8-isoprostane), as measured by means of an assay kit, after about 2 hours from the first administration of the product under study, following the 7 days of administration of the product under study (Visit 2: Day 7, and Visit 4: Day 28), and at the end of the 15-day washout period (Visit 3, Day 22) 4. Inflammatory cytokines (blood and urinary IL-6 and blood IL-10), as measured by means of an assay kit, after about 2 hours from the first administration of the product under study, following the 7 days of administration of the product under study (Visit 2: Day 7 and Visit 4: Day 28), and at the end of the 15-day washout period (Visit 3: Day 22). | — |
Countries
Italy
Contacts
Public ContactLorenza Pratali
Outcome results
None listed