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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaquat University of Medical & Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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