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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• University of Rome Tor Vergata — Roma

Идентификаторы

NCT: NCT07502807 · Ref. No. 97/20.04.2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗