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

June 25, 2018 updated by: Azienda Ospedaliera Universitaria Policlinico "G. Martino"

A Randomized, Double-blinded, Clinical Trial on Effects of a Food Supplement on Cognitive and Neuropsychological Functioning in Healthy Older Adults.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitis vinifera extract
Vitis vinifera extract 250 mg/day orally administered for 12 weeks.
Dietary supplement: Vitis vinifera extract
Other Names:
  • Cognigrape®
Placebo Comparator: Placebo
Placebo orally administered once a day for 12 weeks.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 weeks
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.
Up to 12 weeks.
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.
Up to 12 weeks.
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.
Up to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Investigators

  • Principal Investigator: Umberto Alecci, MD, Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhCT-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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