Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

March 13, 2017 updated by: Giuseppe Lembo, Neuromed IRCCS
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • (is)
      • Pozzilli, (is), Italy, 86077
        • IRCCS Neuromed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutraceutical
Treated with nutraceutical compound
Dietary supplement: Nutraceutical compound
Placebo Comparator: Placebo
Treated with placebo
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function assessed by neuropsychological tests
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMB04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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