Healthy subjects with mild to moderate joint discomfort, overweight and who practise sports. Musculoskeletal Diseases
Conditions
Interventions
The active product will be tested in two formulations containing different amounts of Sodium Hyaluronate (ExceptionHyal®Jump - one with twice the dose of the other), while the placebo contains the sam
Sponsors
ROELMI HPC S.R.L., Via Celeste Milani 24/26 – 21040 Origgio (VA), Italy
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 25 and 55 years (extremes included) 4. Subjects with mild to moderate joint discomfort (not related to any underlying pathology) * 5. Subjects who are overweight ** 6. Subjects who practice sports*** 7. Subjects registered with national health service 8. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 9. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 10. Subjects 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 11. Subjects who commit not to change their daily routine or lifestyle during the study **** 12. Subjects 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 13. Subjects informed about the test procedures who have signed a consent form and privacy agreement * Discomfort on palpation and perceived joint discomfort from 4 to 8 (extremes included) ** BMI between 25 kg/m² and 29.9 kg/m². According to the World Health Organization (WHO) BMI Classification. *** 45 to 60 minutes of non-competitive training, 1 to 2 times per week. Participants will avoid excessive strain as instructed by the physiotherapist on the joint causing the greatest discomfort at baseline visit, which will be the joint investigated throughout the study. **** 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. Subjects who do not meet the inclusion criteria 2. Female subjects who are postmenopausal 3. Subjects with 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. Subjects participating or planning to participate in other clinical trials 5. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 6. Subjects that have food intolerances or food allergies to ingredients of the study product 7. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator ****** 8. Subjects who are 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 one month) 9. Subjects admitted to a health or social facility 10. Subjects planning a hospitalization during the study 11. Subjects not able to be contacted in case of emergency 12. Subjects deprived of freedom by administrative or legal decision or under guardianship 13. Subjects who have or have had a history of alcohol or drug addiction 14. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 15. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential). ***** Including musculoskeletal disease, skeletal neuromuscular injuries, autoimmune diseases ****** Including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Corticosteroids, Pain medications taken daily or on a regular basis
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed