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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets
Inactive compound in oral tablets
U.O.C. Geriatria e Lungodegenza - P.O. SS Filippo e Nicola di Avezzano
Avezzano, L'Aquila, Italy
Change in Trail Making Test (TMT) B Between Baseline and End of Treatment
Change in Trail Making Test (TMT) B scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Time frame: 8 weeks - from baseline to end of study
Change Trail Making Test (TMT) A Between Baseline and End of Treatment
Change in Trail Making Test (TMT) A scores from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Time frame: 8 weeks - from baseline to end of study
Change in Trail Making Test (TMT) B - Trail Making Test (TMT) A Between Baseline and End of Treatment
Change in Trail Making Test (TMT) B score minus Trail Making Test (TMT) A score from baseline (V2) to 8 weeks of treatment (V4). The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Time frame: 8 weeks - from baseline to end of study
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