Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02572219

Enrollment

Registered

2015-10-08

Start date

2015-11-30

Completion date

2016-11-30

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTNutraceutical compound

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cognitive function assessed by neuropsychological tests	6 months	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026