Effect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype Adults

March 27, 2026 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

Effect of Neurofast® Supplementation on Anxiety and Cardiovascular Outcomes in the Psycho-Cardio Phenotype: A Prospective Real-World Interventional Observational Study

This study aims to evaluate anxiety and cardiovascular outcomes in individuals with the psycho-cardio phenotype, characterized by clinically relevant anxiety symptoms with or without established cardiovascular disease (CVD). The study will be conducted as a prospective, real-world interventional study over 12 weeks.

Participants will be allocated to either a group receiving Neurofast® supplementation (2 tablets per day) or a control group receiving no additional treatment. Psychological assessments will include the Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and Cardiac Anxiety Questionnaire (CAQ). Cardiovascular parameters, including heart rate, blood pressure, and electrocardiographic (ECG) measures, will also be evaluated.

The primary objective is to assess changes in anxiety symptoms and heart rate over 12 weeks. Secondary objectives include evaluation of depressive symptoms, cardiovascular parameters, and treatment adherence in a real-world clinical setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Mental health and cardiovascular disease are closely interconnected, with anxiety symptoms influencing cardiovascular outcomes, quality of life, and adherence to treatment. This study focuses on individuals presenting with the psycho-cardio phenotype, defined as the coexistence of clinically relevant anxiety symptoms with or without established cardiovascular disease.

This is a prospective, real-world interventional study conducted in a clinical practice setting. Participants will be followed for 12 weeks with repeated psychological and cardiovascular assessments. Eligible participants will include adults aged 18-70 years with GAD-7 ≥ 5 and/or elevated CAQ scores and stable clinical status.

Participants will be allocated into two groups: one group receiving Neurofast® supplementation (2 tablets daily, one in the morning and one in the evening) and one control group receiving no additional treatment. Assessments will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks.

Psychological assessments will include GAD-7 for anxiety, PHQ-9 for depressive symptoms, and CAQ for cardiac-related anxiety. Cardiovascular assessments will include electrocardiography (ECG), heart rate, and blood pressure measurements. Laboratory evaluations, including glucose, lipid profile, and kidney function, will also be performed.

The primary outcome is the change in anxiety scores (GAD-7 and CAQ) and heart rate at 12 weeks. Secondary outcomes include changes in depressive symptoms (PHQ-9), cardiovascular parameters, and assessment of treatment adherence and tolerability in a real-world clinical context.

The study will be conducted in accordance with the Declaration of Helsinki and has received ethics approval from the Calabria Region Ethics Committee (Ref. No. 97/20.04.2023). All participants will provide written informed consent prior to enrollment.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-70 years (both sexes)
  • GAD-7 ≥ 5 and/or elevated CAQ score
  • PHQ-9 < 20
  • Stable clinical status (either no cardiovascular disease or stable cardiovascular disease)
  • Ability to provide informed consent

Exclusion Criteria:

  • Severe chronic kidney disease (eGFR < 50 ml/min)
  • Severe hepatic impairment
  • Psychotic disorders, bipolar disorder, or acute major depression
  • Unstable psychiatric or pharmacological treatment (<3 months)
  • Pregnancy or breastfeeding
  • Known allergy or intolerance to investigational treatments (if applicable)

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofast® Supplementation
Participants in this group will receive Neurofast® supplementation at a dose of 2 tablets per day (one tablet in the morning and one tablet in the evening) for a duration of 12 weeks, in addition to standard clinical care in a real-world setting.
Dietary supplement: Neurofast® supplement
Neurofast® is a nutraceutical formulation administered orally in tablet form and evaluated for its potential effects on psychological and cardiovascular parameters in individuals with the psycho-cardio phenotype.
Other Names:
  • Neurofast®
No Intervention: No Additional Treatment Control
Participants in this group will not receive Neurofast® supplementation and will continue with standard clinical care without any additional intervention during the 12-week follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Time Frame: Baseline to Week 12
Change in anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Baseline to Week 12
Change in Cardiac Anxiety Questionnaire (CAQ) score
Time Frame: Baseline to Week 12
Change in cardiac-related anxiety measured using the Cardiac Anxiety Questionnaire (CAQ). Higher scores indicate greater cardiac-related anxiety.
Baseline to Week 12
Change in heart rate measured by standard 12-lead ECG
Time Frame: Baseline to Week 12
Heart rate (beats per minute) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Baseline to Week 12
Change in PR interval measured by standard 12-lead ECG
Time Frame: Baseline to Week 12
PR interval (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Baseline to Week 12
Change in QRS duration measured by standard 12-lead ECG
Time Frame: Baseline to Week 12
QRS duration (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Baseline to Week 12
Change in corrected QT interval (QTc) measured by standard 12-lead ECG
Time Frame: Baseline to Week 12
Corrected QT interval (QTc, milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time Frame: Baseline to Week 12
Change in depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating greater depressive severity.
Baseline to Week 12
Change in blood pressure (mmHg)
Time Frame: Baseline to Week 12
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) during clinical visits.
Baseline to Week 12
Change in standard 12-lead electrocardiographic parameters
Time Frame: Baseline to Week 12
Electrocardiographic parameters routinely obtained from a standard 12-lead ECG, including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval (QTc), will be assessed and compared between baseline and Week 12.
Baseline to Week 12
Treatment adherence
Time Frame: Up to Week 12
Assessment of adherence to Neurofast supplementation during the study period in a real-world clinical setting.
Up to Week 12

Collaborators and Investigators

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

Sponsor

Liaquat University of Medical & Health Sciences

Collaborators

University of Rome Tor Vergata

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 (Estimated)

April 7, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ref. No. 97/20.04.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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