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

NCT03145987 | Completed DMC

• 1 other identifier: PhCT-3
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Decline; Neurophysiologic Abnormality

Keywords

Cognitive functioning; Neuropsychological status; Vitis vinifera

Outcome Measures

Primary Outcomes (4)

• Mini Mental State Examination

  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

  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

  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

  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.

Study Arms (2)

Vitis vinifera extract

EXPERIMENTAL

Vitis vinifera extract 250 mg/day orally administered for 12 weeks.

Dietary Supplement: Vitis vinifera extract

Placebo

PLACEBO COMPARATOR

Placebo orally administered once a day for 12 weeks.

Other: Placebo

Interventions

Vitis vinifera extract DIETARY_SUPPLEMENT

Also known as: Cognigrape®

Vitis vinifera extract

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Related Publications (21)

• Andreescu C, Belnap BH, Rollman BL, Houck P, Ciliberti C, Mazumdar S, Shear MK, Lenze EJ. Generalized anxiety disorder severity scale validation in older adults. Am J Geriatr Psychiatry. 2008 Oct;16(10):813-8. doi: 10.1097/JGP.0b013e31817c6aab.

  PMID: 18827227 BACKGROUND

• Asha Devi S, Sagar Chandrasekar BK, Manjula KR, Ishii N. Grape seed proanthocyanidin lowers brain oxidative stress in adult and middle-aged rats. Exp Gerontol. 2011 Nov;46(11):958-64. doi: 10.1016/j.exger.2011.08.006. Epub 2011 Aug 16.

  PMID: 21871550 BACKGROUND

• Assuncao M, de Freitas V, Paula-Barbosa M. Grape seed flavanols, but not Port wine, prevent ethanol-induced neuronal lipofuscin formation. Brain Res. 2007 Jan 19;1129(1):72-80. doi: 10.1016/j.brainres.2006.10.044. Epub 2006 Dec 6.

  PMID: 17156755 BACKGROUND

• Fremont L, Belguendouz L, Delpal S. Antioxidant activity of resveratrol and alcohol-free wine polyphenols related to LDL oxidation and polyunsaturated fatty acids. Life Sci. 1999;64(26):2511-21. doi: 10.1016/s0024-3205(99)00209-x.

  PMID: 10403511 BACKGROUND

• He Q, Yang SY, Wang W, Wu ZJ, Ma HL, Lu Y. Proanthocyanidins affects the neurotoxicity of Abeta25-35 on C57/bl6 mice. Eur Rev Med Pharmacol Sci. 2016;20(4):679-84.

  PMID: 26957270 BACKGROUND

• Oliboni LS, Dani C, Funchal C, Henriques JA, Salvador M. Hepatoprotective, cardioprotective, and renal-protective effects of organic and conventional grapevine leaf extracts on Wistar rat tissues. An Acad Bras Cienc. 2011 Dec;83(4):1403-11. doi: 10.1590/s0001-37652011000400027.

  PMID: 22146965 BACKGROUND

• Shukitt-Hale B, Carey A, Simon L, Mark DA, Joseph JA. Effects of Concord grape juice on cognitive and motor deficits in aging. Nutrition. 2006 Mar;22(3):295-302. doi: 10.1016/j.nut.2005.07.016. Epub 2006 Jan 18.

  PMID: 16412610 BACKGROUND

• Wang YJ, Thomas P, Zhong JH, Bi FF, Kosaraju S, Pollard A, Fenech M, Zhou XF. Consumption of grape seed extract prevents amyloid-beta deposition and attenuates inflammation in brain of an Alzheimer's disease mouse. Neurotox Res. 2009 Jan;15(1):3-14. doi: 10.1007/s12640-009-9000-x. Epub 2009 Feb 10.

  PMID: 19384583 BACKGROUND

• Hartman RE, Shah A, Fagan AM, Schwetye KE, Parsadanian M, Schulman RN, Finn MB, Holtzman DM. Pomegranate juice decreases amyloid load and improves behavior in a mouse model of Alzheimer's disease. Neurobiol Dis. 2006 Dec;24(3):506-15. doi: 10.1016/j.nbd.2006.08.006. Epub 2006 Sep 28.

  PMID: 17010630 BACKGROUND

• Hill NL, Mogle J, Wion R, Munoz E, DePasquale N, Yevchak AM, Parisi JM. Subjective Cognitive Impairment and Affective Symptoms: A Systematic Review. Gerontologist. 2016 Dec;56(6):e109-e127. doi: 10.1093/geront/gnw091. Epub 2016 Jun 23.

  PMID: 27342440 BACKGROUND

• Novitski J, Steele S, Karantzoulis S, Randolph C. The Repeatable Battery for the Assessment of Neuropsychological Status effort scale. Arch Clin Neuropsychol. 2012 Mar;27(2):190-5. doi: 10.1093/arclin/acr119. Epub 2012 Jan 25.

  PMID: 22277124 BACKGROUND

• Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.

  PMID: 11735772 BACKGROUND

• Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.

  PMID: 9845158 BACKGROUND

• Rezai-Zadeh K, Shytle D, Sun N, Mori T, Hou H, Jeanniton D, Ehrhart J, Townsend K, Zeng J, Morgan D, Hardy J, Town T, Tan J. Green tea epigallocatechin-3-gallate (EGCG) modulates amyloid precursor protein cleavage and reduces cerebral amyloidosis in Alzheimer transgenic mice. J Neurosci. 2005 Sep 21;25(38):8807-14. doi: 10.1523/JNEUROSCI.1521-05.2005.

  PMID: 16177050 BACKGROUND

• Scola G, Conte D, Spada PW, Dani C, Vanderlinde R, Funchal C, Salvador M. Flavan-3-ol compounds from wine wastes with in vitro and in vivo antioxidant activity. Nutrients. 2010 Oct;2(10):1048-59. doi: 10.3390/nu2101048. Epub 2010 Oct 11.

  PMID: 22253995 BACKGROUND

• Seidel S, Dal-Bianco P, Pablik E, Muller N, Schadenhofer C, Lamm C, Klosch G, Moser D, Klug S, Pusswald G, Auff E, Lehrner J. Depressive Symptoms are the Main Predictor for Subjective Sleep Quality in Patients with Mild Cognitive Impairment--A Controlled Study. PLoS One. 2015 Jun 19;10(6):e0128139. doi: 10.1371/journal.pone.0128139. eCollection 2015.

  PMID: 26090659 BACKGROUND

• Wang J, Ferruzzi MG, Ho L, Blount J, Janle EM, Gong B, Pan Y, Gowda GA, Raftery D, Arrieta-Cruz I, Sharma V, Cooper B, Lobo J, Simon JE, Zhang C, Cheng A, Qian X, Ono K, Teplow DB, Pavlides C, Dixon RA, Pasinetti GM. Brain-targeted proanthocyanidin metabolites for Alzheimer's disease treatment. J Neurosci. 2012 Apr 11;32(15):5144-50. doi: 10.1523/JNEUROSCI.6437-11.2012.

  PMID: 22496560 BACKGROUND

• Wang J, Ho L, Zhao W, Ono K, Rosensweig C, Chen L, Humala N, Teplow DB, Pasinetti GM. Grape-derived polyphenolics prevent Abeta oligomerization and attenuate cognitive deterioration in a mouse model of Alzheimer's disease. J Neurosci. 2008 Jun 18;28(25):6388-92. doi: 10.1523/JNEUROSCI.0364-08.2008.

  PMID: 18562609 BACKGROUND

• Vecchio F, Miraglia F, Quaranta D, Granata G, Romanello R, Marra C, Bramanti P, Rossini PM. Cortical connectivity and memory performance in cognitive decline: A study via graph theory from EEG data. Neuroscience. 2016 Mar 1;316:143-50. doi: 10.1016/j.neuroscience.2015.12.036. Epub 2015 Dec 24.

  PMID: 26724581 BACKGROUND

• Studer J, Donati A, Popp J, von Gunten A. Subjective cognitive decline in patients with mild cognitive impairment and healthy older adults: association with personality traits. Geriatr Gerontol Int. 2014 Jul;14(3):589-95. doi: 10.1111/ggi.12139. Epub 2013 Aug 29.

  PMID: 23992484 BACKGROUND

• Small GW, Chen ST, Komo S, Ercoli L, Miller K, Siddarth P, Kaplan A, Dorsey D, Lavretsky H, Saxena S, Bookheimer SY. Memory self-appraisal and depressive symptoms in people at genetic risk for Alzheimer's disease. Int J Geriatr Psychiatry. 2001 Nov;16(11):1071-7. doi: 10.1002/gps.481.

  PMID: 11746653 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

whole grape extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Umberto Alecci, MD

  Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo controlled study.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share