Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
Effect of an Antioxidants Mix on Cognitive Performance and Well Being: The Bacopa, Licopene, Astaxantina, Vitamin B12
Nine-weeks double-blind, randomized, placebo-controlled, parallel-arm superiority study.

 The aim of this study is to evaluate the influence of a mix of four bioactive compounds -
 bacopa, lycopene, astaxanthin and vitamin B12 - on cognitive performance, mood state and
 well-being in subjects aged ≥ 60 years with no evidence of cognitive dysfunction.

 The primary objective of the study is to evaluate the changes in Trial Making Test (TMT)
 scores from baseline (V2) to 8 weeks of treatment (V4), analyzed in the following
 hierarchical order: TMT-B, TMT-A and TMT B-A.

 Secondary objectives of this study are to evaluate changes from baseline (V2) to 8 weeks of
 treatment (V4) in Verbal Fluency Test (VFT) score, Montreal Cognitive Assessment (MoCA)
 score, Mini Mental State Examination (MMSE) score, Rey Auditory Verbal Learning Test (AVLT),
 psychological well-being as assessed by General Health Questionnaire (GHQ-12), mood states as
 assessed by the Profile of Mood Stated (POMS), sexual satisfaction as evaluated by the New
 Sexual Satisfaction Scale (NSSS).

 Changes of metabolic parameters from baseline (V2) to 4 weeks of treatment (V3) and from
 baseline (V2) to 8 weeks of treatment (V4) will be also evaluated as secondary objectives
 (glucose, insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), total
 cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, uric acid).

 Changes of plasma markers of oxidative stress from baseline (V2) to 4 weeks of treatment (V3)
 and from baseline (V2) to 8 weeks of treatment (V4) will be evaluated as secondary objectives
 (8-iso-Prostaglandin F2alpha, Plasma malondialdehyde).

 Finally the safety and tolerability of the study product will be assessed.
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.
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.