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

INTERVENTION: 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 randomized to receive the test product (250 mg in 2 capsules per day, in the morning after breakfast, with a glass of water) and half of the test subjects will be randomized to receive the placebo product. A restricted randomization list will be created using PASS 2008 (PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64‐bit Edition (Microsoft, USA) by a biostatistician and stored in a safe place. The randomization sequence will be stratified using “Efron’s biased coin” algorithm with a 1:1 allocation ratio. The allocation sequence will be concealed from the in‐site study director in sequentially numbered, opaque, and sealed envelopes, reporting the unblinded treatment allocation (based on subject entry number in the study). The A4 sheet reporting the unblinded treatment will be folded to render the envelope impermeable to intense light. A masked allocation sequence will be prepared for the staff delivering the intervention based on the subject entry number in the study. Participants are asked to attend clinic visits at screening and after 14, 28, and 84 days of product intake. During the screening visit, the principal investigator informs the participants about the trial procedure, risks, and benefits. Only participants giving their informed consent are enrolled in the study. The participants are then randomly allocated to use the COGNIGRAPE™ food supplement or the placebo (dummy) product for 84 days. All the measurements/assessments are carried out using non‐invasive procedures. The total duration of each visit is 30 min CONDITION: Elderly subjects with a score = 24 on the Mini‐Mental State Examination (MMSE) ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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 OUTCOME: 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 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)