Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12

Launched by A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L. · Jan 30, 2019

Keywords

ClinConnect Summary

The study has been conducted in 1 Italian clinical site and involved 80 subjects.

Subjects will be randomly allocated to one of the following groups:

* Group I: mix of the four bioactive compounds (bacopa, lycopene, astaxanthin and vitamin B12), once a day for 8 weeks per os;
* Group II: placebo, once a day for 8 weeks per os.

The study is double blind. Neither the study staff at clinical sites (Investigators, nurses, pharmacist) nor the subject was aware of the treatment assigned.

Each participant attended 4 visits over a total period of about 9 weeks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects aged ≥60 years.
• • 2. Subjects who provide written Informed Consent to the study.
• Exclusion Criteria:
• • 1. Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE \<27 or other neurological disorders, thyroid disorders, or inflammatory diseases)
• • 2. Subjects with a score on the Geriatric Depression Scale (GDS) \>11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests
• • 3. Current smokers
• • 4. Habitual users of antioxidant supplements (including vitamins C and E)
• • 5. Habitual consumers of chocolate or other cocoa products (daily consumption of any amount)
• • 6. Subjects under treatments with medications known to have antioxidant properties (including statins and glitazones) or to interfere with cognitive functions (including benzodiazepines and antidepressants)
• • 7. Subjects with hypersensitivity to any component of the study medications
• • 8. Subjects who are participating in or having participated in another clinical trial within the previous three months.