Healthy volunteers who practise sports and with discomfort in the upper limb joints Musculoskeletal Diseases
Conditions
Interventions
The active intervention is a food supplement containing Verbascum thapsus L. extract (Verbalief), while the placebo intervention contains the same excipients without the active extract.
A restricted
Sponsors
BIONAP S.R.L.
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers 2. Caucasian ethnicity 3. Aged between 18 and 45 years (extremes included) 4. Practice sports* 5. Female subjects not in the menstrual bleeding phase of their cycle during the study visits 6. Normal electrocardiogram (ECG) 7. Discomfort in the upper limb joints (not related to any underlying pathology)** 8. Registered with the National Health Service (NHS) 9. Certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 10. Able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 11. Able to respect the instructions given by the Principal Investigator or designated personnel, as well as able to respect the study constraints and specific requirements 12. Commit not to change their daily routine or lifestyle during the study *** 13. On stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 14. Informed about the test procedures who have signed a consent form and privacy agreement *40 to 60 minutes of non-competitive training, two to three times per week **Clinical evaluation of joint wellbeing status from 4 to 8 (extremes included) ***Subjects will keep a diary to ensure that they do not change their exercise and eating habits during the study
Exclusion criteria
Exclusion criteria: 1. Do not meet the inclusion criteria 2. Smokers 3. Any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study **** 4. Participating or planning to participate in other clinical trials 5. Participated in a similar study without respecting an adequate washout period (at least 1 month) 6. Have food intolerances or food allergies to ingredients of the study product 7. Under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator ***** 8. Currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least 1 month) 9. Admitted to a health or social facility 10. Planning a hospitalization during the study 11. Not able to be contacted in case of emergency 12. Deprived of freedom by administrative or legal decision or under guardianship 13. Have or have had a history of alcohol or drug addiction 14. Eating disorders (i.e., bulimia, psychogenic eating disorders, etc) 15. Breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) **** Including musculoskeletal disease, metabolic disease, high blood pressure, asthma, or skeletal neuromuscular injuries ***** Including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Corticosteroids, Chronic pain medications (e.g. Opioid Analgesics), Antidepressants
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed