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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Change in Generalized Anxiety Disorder-7 (GAD-7) score — 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.
Change in Cardiac Anxiety Questionnaire (CAQ) score — Baseline to Week 12 Change in cardiac-related anxiety measured using the Cardiac Anxiety Questionnaire (CAQ). Higher scores indicate greater cardiac-related anxiety.
Change in heart rate measured by standard 12-lead ECG — 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.
Change in PR interval measured by standard 12-lead ECG — Baseline to Week 12 PR interval (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Change in QRS duration measured by standard 12-lead ECG — Baseline to Week 12 QRS duration (milliseconds) will be assessed using a standard 12-lead electrocardiogram and compared between baseline and Week 12.
Change in corrected QT interval (QTc) measured by standard 12-lead ECG — 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.
Trial sites (1)
Facility
City
Region
Status
University of Rome Tor Vergata
Roma
Italy
More Liaquat University of Medical & Health Sciences trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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