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

Sponsor
Liaquat University of Medical & Health Sciences
Study ID
NCT07502807
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Mar 31, 2026
Start date
Apr 7, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Generalized Anxiety Disorder-7 (GAD-7) score [ Time Frame: Baseline to Week 12 ]

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