Healthy volunteer Not Applicable
Conditions
Interventions
The product under study consists of a food supplement based on L-Carnitine. The product is aimed to provide physical energy in a short time (immediate energy) and attention/concentration, without givi
Sponsors
Farmaceutici Procemsa S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Healthy male and female subjects, ? Age between 18 and 60 (extremes included) years old, ? Subjects with waist circumference = 97 cm and BMI<28 1. Subject is in good health and appropriate for exercise as determined by physical examination, medical history 2. The eligible subjects will be recruited for the study after examination and the establishment of a basic level of parameters. Score = 24 on the Mini-Mental State Examination (MMSE) 3. Non-smoker 4. Subject agrees not to use any food supplement until study completion 5. Subject avoiding consumption of any food supplement (for pre-workout / memory improving drugs or food supplements that can interfere with the CNS activity) for at least 4 weeks prior to the study start 6. Subjects willing to avoid caffeine and alcohol assumption for the 24 hours prior to the test visits 7. Subjects who have not been recently involved in any other similar study (at least one month of wash-out), 8. Willingness to not vary the normal diet and daily routine (at the beginning of the study volunteers will list their usual routine: sports activities, sleeping habits, etc.) 9. Reading, understanding and signing approval of the informative consent 10. Available and willing to follow the procedure of the study protocol 11. Subjects registered with National Health Service (NHS) 12. Subjects certifying the truthfulness of the personal data disclosed to the investigator
Exclusion criteria
Exclusion criteria: 1. Subject does not meet the inclusion criteria 2. Subject with known or suspected food intolerance or food allergy 3. Any condition that the principal investigator deems inappropriate for participation 4. Us of pharmacological treatments known to interfere with the subject’s metabolism/physiology 5. Severe concurrent diseases 6. Having a diagnosed chronic disease (blood, cardio-vascular, psychiatric, neuro-degenerative, diabetes, cancer, liver, gastric, skin, kidney etc.) and/or under medical treatment 7. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated) 8. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function 9. Clinical history with the presence of any relevant disorder or administration of drugs/food supplements that can potentially interfere with the treatment under study 10. Subjects with a history of drug, alcohol and other substance abuse 11. Subjects with active cancers or on chemotherapy 12. Other factors that limit their ability to cooperate during the study 13. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) 14. Subjects not able to be contacted in case of emergency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following outcome will be measured at baseline and after 90 minutes after 1 and 3 product intake: 1. Weight measured using scales 2. Body mass index measured using scales for weight measurement and a meter for height measurement 3. Endurance strength measured by a Chest press “repetitions to failure” test (70 % - 1 repetition maximum [1RM]) followed by a Leg press “repetitions to failure” test (70 % - 1RM) after a 15 minutes rest period 4. Muscle power measured by 30 ‘’ arms Wingate Anaerobic Power Test (aWAnT) followed by 30 ‘’ legs Wingate Anaerobic Power Test (lWAnT) after a 15 minutes rest period The following outcome will be measured at baseline and after 90 minutes after 1 product intake: 5. Cognitive assessment measured by the Mini-Mental State Examination (MMSE) questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Product safety outcomes will be measured at baseline and after 1, 3, and 10 product intake: 1. Heart rate measured using a sphygmomanometer 2. Blood pressure measured using a sphygmomanometer 3. Electrocardiogram (ECG) measured using an electrocardiograph | — |
Countries
Italy
Contacts
Public ContactVincenzo Nobile
Outcome results
None listed