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

NCT07502807 | Not Yet Recruiting DMC

• 1 other identifier: Ref. No. 97/20.04.2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (6)

• Change in Generalized Anxiety Disorder-7 (GAD-7) score

  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

  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

  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

  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

  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

  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 Outcomes (4)

• Change in Patient Health Questionnaire-9 (PHQ-9) score

  Baseline to Week 12

• Change in blood pressure (mmHg)

  Baseline to Week 12

• Change in standard 12-lead electrocardiographic parameters

  Baseline to Week 12

• Treatment adherence

  Up to Week 12

Study Arms (2)

Neurofast® Supplementation

EXPERIMENTAL

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

No Additional Treatment Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Neurofast®

Neurofast® Supplementation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rome Tor Vergata: collaborator
• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

University of Rome Tor Vergata

Roma, 00133, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study conducted in a real-world clinical practice setting; no masking or blinding of participants, investigators, or outcome assessors is applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be allocated to one of two parallel groups: a group receiving Neurofast® supplementation (2 tablets per day) and a control group receiving no additional treatment, with follow-up over 12 weeks in a real-world clinical setting.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 31, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

IT (1)