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NCT Number: NCT07502807

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Cardiovascular Diseases Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rome Tor Vergata

Roma, 00133, Italy

Location contact

Dr. Barbara Pala, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neurofast® supplement

Dietary 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®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Treatment adherence

    Time frame: Up to Week 12

    Assessment of adherence to Neurofast supplementation during the study period in a real-world clinical setting.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Rome Tor Vergata

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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