Elderly subjects with a score = 24 on the Mini-Mental State Examination (MMSE) Mental and Behavioural Disorders
Conditions
Interventions
COGNIGRAPE™ is a standardized powder extract from red grape juice containing high concentrations of active grape substances such as anthocyanins and proantocyanidins. Half of the test subjects will be
Sponsors
BIONAP srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Attention deficit measured using the "test delle campanelle" 90 minutes after the first product intake 2. Cognitive impairment (problems with thinking, communication, understanding, and memory) measured using the Mini-Mental State Examination (MMSE) questionnaire at 14, 28, and 84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neuropsychological Status measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) questionnaire at screening and after 14, 28, and 84 days 2. Sustained and selective attention measured using a continuous performance test (CPT) questionnaire at screening and after 14, 28, and 84 days 3. Different cognitive domains (attention, memory, executive functions, and perceptive and praxis abilities) measured using the Short Neuropsychological Examination version 2 (ENB-2) questionnaire at screening and after 14, 28, and 84 days 4. Mood status measured using the Profile of Mood States (POMS) questionnaire at screening and after 14, 28, and 84 days | — |
Countries
Italy
Outcome results
None listed