Clinical trial for the evaluation of the efficacy of a food supplement in improving of strength, power and mental alertness

Farmaceutici Procemsa S.p.A.0 sites60 target enrollmentNovember 14, 2022

Overview

No summary available.

Registry

who.int

Start Date

November 14, 2022

End Date

January 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Farmaceutici Procemsa S.p.A.

•?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),

•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