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 个研究点目标入组 60 人开始时间: 2022年11月14日最近更新: 2022年11月28日

适应症

试验速览

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•?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

•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

发起方

Farmaceutici Procemsa S.p.A.