Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Older Adults.
Condition: Cognitive Decline; Neurophysiologic Abnormality
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The increase in life expectancy is associated with a gradual aging of the population so
      creating new needs arising from this new situation. Memory ability declines with age and
      memory deficits are regarded as an initial symptom of dementia of Alzheimer's Disease (AD)
      type, one of the most prevalent cognitive disorders in older people. States and scientific
      community have been called to find preventive strategies acting against the consequent
      physiological cognitive decline with the aim to attenuate the increase of dementia. Numerous
      studies have shown that polyphenolic compounds derived from multiple dietary sources, and
      more specifically the polyphenolic compounds found in grapes (GP), are able to attenuate the
      cognitive impairment and in reducing neuropathological lesions in the brain in experimental
      animal models for the study of Alzheimer's Disease (AD) .

      In recent years, several in vivo studies have shown that oral administration of polyphenols
      from grapes improves antioxidant status in the brain and prevents neuronal damage induced by
      free radicals. The intake of proanthocyanidins, especially in the monomeric form, showed to
      produce an improvement of cognitive function in an Alzheimer's disorder animal model.

      A randomized, double-blind, placebo-controlled clinical trial was designed by the
      investigators with the aim to evaluate potential beneficial effects of a Vitis vinifera-based
      food supplement on cognitive functioning and neuropsychological status in healthy older
      adults aging 55-75 years.

      For the enrollment, mental status was evaluated through the Mini-Mental State Exam, a test
      able to provide quickly a screen of orientation, providing a rapid screen of recall,
      language, orientation, registration, attention and calculation. 111 subjects were recruited
      and, after obtaining the informed consent, successively randomly divided in two groups: Group
      1, N = 57 to be treated for 12 weeks with Vitis vinifera extract (verum 250 mg/day); Group 2,
      N = 54 to be treated for 12 weeks with placebo. Cognitive functioning and neuropsychological
      status were evaluated at the beginning (before treatment) and a the end of treatment by using
      Mini Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety
      Rating Scale (HARS) and Repeatable Battery for the Assessment of Neuropsychological Status.
    

Detailed description: 
      Study design The study was a randomized into a two-group, parallel, placebo-controlled
      clinical trial to assess the efficacy of a food supplement containing vitis vinifera extract
      developed for cognitive and neuropsychological functioning in healthy older adults.

      Screening Mental status was evaluated through the MMSE, a test able to provide quickly a
      screen of orientation, providing a rapid screen of recall, language, orientation,
      registration, attention and calculation. To study the effects on cognitive functioning and
      neuropsychological status participants were also subjected to the Beck Depression Inventory
      (BDI) and Hamilton Anxiety Rating Scale (HARS).

      At screening (visit 1, day 0) after giving informed consent, subjects underwent medical
      history, physical examination, and vital signs. All subjects got oral and written information
      about the study and gave written informed consent to participate before inclusion in the
      trial. After screening and evaluation of baseline scores, included subjects were randomly
      allocated to one of two groups treated as follows: Group 1, N = 57 to be treated with
      Cognigrape capsule (verum 250 mg/day); Group 2, N = 54 to be treated with placebo .
      Randomisation by blocks of 3 (2 + 1) was double-blinded. Successive blocks were balanced by
      2s. Neither subjects recruited for the study nor investigators were able to differentiate the
      two different treatments.

      The Mini-Mental State Examination is composed of 12 items exploring through 22 trials verbal
      and performance, 7 cognitive functions: temporal and spatial orientation; immediate memory;
      attention and calculation; recall memory; language; praxia visuo-constructive. The
      administration requires a time ranging from 5 to 15 minutes. The score is corrected for age
      and education; the threshold for the purposes of enrollment in the study is set at a score ≥
      24. The MMSE score between 18 and 24 is an indication of a compromised moderate to mild,
      while a score of 25 is considered borderline, from 26 to 30 is indicative of normality
      cognitive. For this reason a score limit of 24 including masked potential light cognitive
      decline in healthy adults was chosen.

      Beck Depression Inventory is a self-report instrument measuring the severity of depression.
      The Beck Depression Inventory (BDI) Short Form, a prominently and frequently cited,
      self-reported measure of depression was used. The 13-item questionnaire assesses 4 major
      components of depression: behavioral, affective, cognitive, and physiological. Numerical
      values assigned to each statement range from 0 to 3 indicating increasing severity. According
      to Beck's clinical criteria, a score between 8 and 15 indicates moderate depression and 16
      severe depression.

      Questionnaire is composed of in 21 questions with multiple choice response suitable to
      investigate the presence of depressive symptoms; aspects investigated by the test are:
      sadness, pessimism, sense of failure, dissatisfaction, guilty, free expectation,
      self-disappointment, self-accusation, suicidal ideas, crying, irritability, indecision,
      doubt, social withdrawal, devaluation of its image body, work efficiency decrease, sleep
      disturbance, fatigue, decreased appetite, weight loss, somatic concerns, loss of libido. The
      questionnaire has been administered immediately before the beginning (Day 0) and at the end
      of treatment (after 12 weeks).

      Hamilton Anxiety Rating Scale is a scale evaluating anxiety through the investigation of 15
      different areas (such as insomnia, mood, somatic symptoms). Each of the 15 areas is composed
      of a minimum of 3 to a maximum of 8 items to each of which is given a score from 0 to 6,
      depending on the severity of symptoms. Subsequently the total value is calculated for each
      area, using a score of 0 (absent), 1 (mild), 2 (moderate), 3 (severe), or 4 (very severe)
      points, based on the overall severity of symptoms investigating each specific area. The total
      score, which has been called "whole", is calculated by adding the points of each of the 15
      areas surveyed. The rating of the scale may vary from 0 to 56. A total score around 18 is
      considered indicative of a pathological state.

      Repeatable Battery for the Assessment of Neuropsychological Status is a quick and complete
      neuropsychological battery, consisting of two forms ( "A" and "B") associated with identical
      difficulty degrees, each divided into 12 subtests administered to evaluate 5 different
      cognitive domains: attention, language, visuospatial/constructional abilities immediate
      memory and delayed memory.

      Cognitive-neuropsychological assessment was performed at baseline (o day) and after the 12
      weeks of treatment period. Measures included MMSE, BDI, HARS, RBANS.
    

Intervention name(s): Vitis vinifera extract; Placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): Cognigrape®
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, placebo controlled study.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cognitive functioning; Neuropsychological status; Vitis vinifera