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A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults

Introduction: Gradual population aging is creating a new set of needs in the general population. Memory capacity decreases with age, and memory deficits are considered an early symptom of Alzheimer’s Disease (AD), one of the most prevalent cognitive disorders in older people. Numerous studies have s...

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Autores principales: Calapai, Gioacchino, Bonina, Francesco, Bonina, Andrea, Rizza, Luisa, Mannucci, Carmen, Arcoraci, Vincenzo, Laganà, Germana, Alibrandi, Angela, Pollicino, Concetta, Inferrera, Santi, Alecci, Umberto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5671585/
https://www.ncbi.nlm.nih.gov/pubmed/29163162
http://dx.doi.org/10.3389/fphar.2017.00776
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author Calapai, Gioacchino
Bonina, Francesco
Bonina, Andrea
Rizza, Luisa
Mannucci, Carmen
Arcoraci, Vincenzo
Laganà, Germana
Alibrandi, Angela
Pollicino, Concetta
Inferrera, Santi
Alecci, Umberto
author_facet Calapai, Gioacchino
Bonina, Francesco
Bonina, Andrea
Rizza, Luisa
Mannucci, Carmen
Arcoraci, Vincenzo
Laganà, Germana
Alibrandi, Angela
Pollicino, Concetta
Inferrera, Santi
Alecci, Umberto
author_sort Calapai, Gioacchino
collection PubMed
description Introduction: Gradual population aging is creating a new set of needs in the general population. Memory capacity decreases with age, and memory deficits are considered an early symptom of Alzheimer’s Disease (AD), one of the most prevalent cognitive disorders in older people. Numerous studies have shown that grape polyphenolic compounds (GPs) are able to attenuate cognitive impairment and reduce brain lesions in experimental AD animal models. These GP effects are associated with improvement in brain antioxidant status and prevention of free radical-induced neuronal damage. We designed a randomized, double-blind, placebo-controlled clinical trial to investigate the potential beneficial effects of a Vitis vinifera-based dietary supplement on cognitive function and neuropsychological status in healthy older adults. Methods: One-hundred eleven subjects were recruited and randomly divided in two groups: one group received the V. vinifera-based dietary supplement Cognigrape(®) for 12 weeks (250 mg/day) and the second group received placebo over the same period of time. Before and after the end of the supplementation period, cognitive function and neuropsychological status were evaluated using the Mini-Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety Rating Scale (HARS), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) evaluations. Results: MMSE scores were significantly improved after supplementation with Cognigrape(®) in comparison with baseline levels (p < 0.0001) and placebo (r = 0.59, 0.95% CI 0.11, 1.22; p < 0.0001). Cognigrape(®) supplementation produced a significant reduction in BDI (-15.8%) and HARS (-24.9%) scores with respect to baseline levels (p < 0.0001) and placebo (p < 0.0001 for BDI and p < 0.05 for HARS). RBANS total score was significantly improved by Cognigrape(®) with respect to baseline levels and placebo (r = 0.55, 0.95% CI 0.48, 6.07; p < 0.0001). The comparison with the placebo revealed improvements in several parameters among participants receiving Cognigrape(®): attention (p < 0.001); language (p < 0.05); immediate memory (p < 0.0001); and delayed memory (p < 0.0001). Visuospatial/constructional abilities were not modified. During the study, no adverse effects were detected. Conclusion: The results show that 12 weeks of Cognigrape(®) supplementation is safe, can improve physiological cognitive profiles, and can concurrently ameliorate negative neuropsychological status in healthy older adults.
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spelling pubmed-56715852017-11-21 A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults Calapai, Gioacchino Bonina, Francesco Bonina, Andrea Rizza, Luisa Mannucci, Carmen Arcoraci, Vincenzo Laganà, Germana Alibrandi, Angela Pollicino, Concetta Inferrera, Santi Alecci, Umberto Front Pharmacol Pharmacology Introduction: Gradual population aging is creating a new set of needs in the general population. Memory capacity decreases with age, and memory deficits are considered an early symptom of Alzheimer’s Disease (AD), one of the most prevalent cognitive disorders in older people. Numerous studies have shown that grape polyphenolic compounds (GPs) are able to attenuate cognitive impairment and reduce brain lesions in experimental AD animal models. These GP effects are associated with improvement in brain antioxidant status and prevention of free radical-induced neuronal damage. We designed a randomized, double-blind, placebo-controlled clinical trial to investigate the potential beneficial effects of a Vitis vinifera-based dietary supplement on cognitive function and neuropsychological status in healthy older adults. Methods: One-hundred eleven subjects were recruited and randomly divided in two groups: one group received the V. vinifera-based dietary supplement Cognigrape(®) for 12 weeks (250 mg/day) and the second group received placebo over the same period of time. Before and after the end of the supplementation period, cognitive function and neuropsychological status were evaluated using the Mini-Mental State Examination (MMSE), Beck Depression Inventory (BDI), Hamilton Anxiety Rating Scale (HARS), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) evaluations. Results: MMSE scores were significantly improved after supplementation with Cognigrape(®) in comparison with baseline levels (p < 0.0001) and placebo (r = 0.59, 0.95% CI 0.11, 1.22; p < 0.0001). Cognigrape(®) supplementation produced a significant reduction in BDI (-15.8%) and HARS (-24.9%) scores with respect to baseline levels (p < 0.0001) and placebo (p < 0.0001 for BDI and p < 0.05 for HARS). RBANS total score was significantly improved by Cognigrape(®) with respect to baseline levels and placebo (r = 0.55, 0.95% CI 0.48, 6.07; p < 0.0001). The comparison with the placebo revealed improvements in several parameters among participants receiving Cognigrape(®): attention (p < 0.001); language (p < 0.05); immediate memory (p < 0.0001); and delayed memory (p < 0.0001). Visuospatial/constructional abilities were not modified. During the study, no adverse effects were detected. Conclusion: The results show that 12 weeks of Cognigrape(®) supplementation is safe, can improve physiological cognitive profiles, and can concurrently ameliorate negative neuropsychological status in healthy older adults. Frontiers Media S.A. 2017-10-31 /pmc/articles/PMC5671585/ /pubmed/29163162 http://dx.doi.org/10.3389/fphar.2017.00776 Text en Copyright © 2017 Calapai, Bonina, Bonina, Rizza, Mannucci, Arcoraci, Laganà, Alibrandi, Pollicino, Inferrera and Alecci. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Calapai, Gioacchino
Bonina, Francesco
Bonina, Andrea
Rizza, Luisa
Mannucci, Carmen
Arcoraci, Vincenzo
Laganà, Germana
Alibrandi, Angela
Pollicino, Concetta
Inferrera, Santi
Alecci, Umberto
A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults
title A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults
title_full A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults
title_fullStr A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults
title_full_unstemmed A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults
title_short A Randomized, Double-Blinded, Clinical Trial on Effects of a Vitis vinifera Extract on Cognitive Function in Healthy Older Adults
title_sort randomized, double-blinded, clinical trial on effects of a vitis vinifera extract on cognitive function in healthy older adults
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5671585/
https://www.ncbi.nlm.nih.gov/pubmed/29163162
http://dx.doi.org/10.3389/fphar.2017.00776
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