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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Change in Generalized Anxiety Disorder-7 (GAD-7) score [Time frame: Baseline to Week 12]
• Change in Cardiac Anxiety Questionnaire (CAQ) score [Time frame: Baseline to Week 12]
• Change in heart rate measured by standard 12-lead ECG [Time frame: Baseline to Week 12]
• Change in PR interval measured by standard 12-lead ECG [Time frame: Baseline to Week 12]
• Change in QRS duration measured by standard 12-lead ECG [Time frame: Baseline to Week 12]
• Change in corrected QT interval (QTc) measured by standard 12-lead ECG [Time frame: Baseline to Week 12]

Secondary outcome measures (4)

• Change in Patient Health Questionnaire-9 (PHQ-9) score [Time frame: Baseline to Week 12]
• Change in blood pressure (mmHg) [Time frame: Baseline to Week 12]
• Change in standard 12-lead electrocardiographic parameters [Time frame: Baseline to Week 12]
• Treatment adherence [Time frame: Up to Week 12]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• University of Rome Tor Vergata — Roma

Identifiers

NCT: NCT07502807 · Ref. No. 97/20.04.2023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗