Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Neuromed IRCCS12 enrolled

Overview

Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

Nutraceutical compoundDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent; * Males or females between 40 and 65 years of age; * Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg). Exclusion Criteria: * Previous acute myocardial infarction (AMI); * Previous stroke and/or transient ischemic attack (TIA); * Diabetes mellitus; * History of atrial fibrillation or other severe arrhythmias; * Severe cardiovascular diseases; * Renal pathologies (creatinine \> 1.4 mg/dL); * Preexisting psychiatric pathologies; * Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy; * Diagnosis of dementia; * Depression; * Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.

Locations (1)

IRCCS Neuromed

Pozzilli, (is), Italy

Outcomes

Primary Outcomes

Cognitive function assessed by neuropsychological tests

Patients will be subjected to Montreal Cognitive Assessment (MoCA), Verbal fluency test, Word coupling test, Stroop test, and Instrumental Activities of Daily Living - IADL test. Assessments of cognitive functions will be performed by using unique score measurements defined in Units on a Scale.

Time frame: 6 months

Data from ClinicalTrials.gov

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