Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Neuromed IRCCS

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Nutraceutical compound

Study type

Interventional

Funder types

Other

Identifiers

NCT02572219

LMB04

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No 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.