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Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Older Adults.

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ClinicalTrials.gov Identifier: NCT03145987
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Brief 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.


Condition or disease Intervention/treatment Phase
Cognitive Decline Neurophysiologic Abnormality Dietary Supplement: Vitis vinifera extract Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded, placebo controlled study.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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 for 12 weeks. Neither subjects recruited for the study nor investigators knew the content of sachets or were able to differentiate the two different treatments.
Primary Purpose: Prevention
Official Title: A Randomized, Double-blinded, Clinical Trial on Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Healthy Older Adults.
Actual Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vitis vinifera extract
Vitis vinifera extract 250 mg/day orally administered for 12 weeks.
Dietary Supplement: Vitis vinifera extract
Other Name: Cognigrape®

Placebo Comparator: Placebo
Placebo orally administered once a day for 12 weeks.
Other: Placebo



Primary Outcome Measures :
  1. Mini Mental State Examination [ Time Frame: Up to 12 weeks ]
    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.

  2. Beck Depression Inventory [ Time Frame: Up to 12 weeks. ]
    It is a self-report instrument measuring the severity of depression. The Beck Depression Inventory (BDI) Short Form was used. BDI is a prominently and frequently cited, self-reported measure of depression. 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.

  3. Hamilton Anxiety Rating Scale [ Time Frame: Up to 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.

  4. Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: Up to 12 weeks. ]
    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.



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age over 55 years; italian speaking and understanding; no using food supplements for cognitive functioning two weeks before enrolling and during the study period; score > or = 24 at Mini-Mental State Exam (MMSE).

Exclusion Criteria:

  • age < 55 or > 75 years, or AD or other related disorders, psychiatric or neurological diseases (including aphasia, sensory, motor or visual disturbances which could affect the test results), cancer, coagulation disorders, cardiovascular, lung, kidney, thyroid, liver, gastrointestinal disease or insulin-dependent diabetes, excessive consumption of alcohol or substance abuse/dependence; more than 3 medical hospitalizations last year or subjects taking coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants or any medications for cognitive functioning.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145987


Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Investigators
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Principal Investigator: Umberto Alecci, MD Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.
Publications:

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Responsible Party: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
ClinicalTrials.gov Identifier: NCT03145987    
Other Study ID Numbers: PhCT-3
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliera Universitaria Policlinico "G. Martino":
Cognitive functioning
Neuropsychological status
Vitis vinifera
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders