Testing plant-derived micronutrients (polyphenols) as food supplements to prevent/improve cognitive decline in ageing people

Not Applicable

• Conditions: Elderly subjects with a score = 24 on the Mini-Mental State Examination (MMSE); Mental and Behavioural Disorders

• Registration Number: ISRCTN10100061
• Lead Sponsor: BIONAP srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-19
• Last Update Posted: 5 August 2022
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified