Assessment of the efficacy of the food supplement COGNIGRAPE™ in preventing the cognitive impairment in an aged population: double-blind, randomized, placebo-controlled clinical study.

BIONAP srl0 个研究点目标入组 120 人开始时间: 2022年7月19日最近更新: 2022年8月5日

适应症

试验速览

暂无简介。

•1. Healthy individuals aged 55 years old and over
•2. Reading, understanding, and signed approval of the informative consent
•3. Available and willing to follow the procedure of the study protocol
•4. The eligible subjects will be recruited for the study after examination and the establishment of a basic level of parameters, including scoring = 24 on the Mini-Mental State Examination (MMSE)

•1. Aged 54 years old and under
•2. Clinical history with the relevant presence of any disorder or administration of drugs/food supplements that can potentially interfere with the treatment under study
•3. Consumption of any memory-improving drugs or food supplements that can interfere with the CNS activity
•4. Consumption of food or beverage enriched in polyphenols 24 hours before each visit
•5. Smokers
•6. Lack of compliance, defined as not using the correct CognigrapeTM dose or placebo for >1 week, and inability to give informed consent
•7. BMI > 30
•8. Pregnant and lactating women
•9. Excessive alcohol consumption (> 5 drinks/week)
•10. A history of drug, alcohol and other substance abuse
•11. Known food intolerance or food allergy
•12. Involved in a clinical or food study within the previous month
•13. Unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
•14. A history of paralysis or cerebral vascular accident
•15. Active cancers or on chemotherapy
•16. Other factors that limit their ability to cooperate during the study

发起方