Efficacy and Safety of a New Nutraceutical Formulation to Attenuate the Chronic Low-grade Inflammation in Patients with Chronic Diseases

Introduction: Chronic low-grade inflammation is a recognized risk factor for several chronic diseases, including metabolic, cardiovascular, and neurodegenerative disorders. This study aimed to evaluate the effects of a new fixed nutraceutical combination as an add-on to the standard therapy in patients with basal inflammation. Methods: We conducted an observational, prospective, open-label study in patients attending the Clinical Pharmacology Operative Unit, University Magna Graecia of Catanzaro, Italy. Fifty-six patients (aged 33–86 years) were enrolled and received one tablet daily of the fixed nutraceutical combination for three months. Laboratory assessments were performed at baseline (T0), three months after the end of treatment (T1), and six months after the end of the study (T2) to evaluate blood inflammatory biomarkers and metabolic parameters. Quality of life and mood were assessed using the SF-36, Zung Self-Rating Anxiety Scale, and Zung Self-Rating Depression Scale, while adverse drug reactions (ADRs) were assessed using the Naranjo scale. Results: All patients completed the study. A time-dependent improvement in quality of life was observed (SF-36: T0, 52 ± 11; T2, 86 ± 7), along with significant reductions in anxiety and depression scores (P < 0.05). Inflammatory biomarkers decreased significantly in a time-dependent manner (P < 0.01). Liver function markers, low-density lipoprotein cholesterol, and triglycerides improved, while high-density lipoprotein cholesterol increased (P < 0.05). No ADRs were reported during the study period. Discussion: The observed clinical benefits are likely due to the synergistic anti-inflammatory and antioxidant effects of the nutraceutical components. Silymarin and glutathione may reduce oxidative stress and protect liver function, while tryptophan may improve mood and emotional well-being. Conclusions: In this cohort, nutraceutical supplementation was well tolerated and associated with improvements in liver function, lipid profile, inflammatory markers, and quality of life. These preliminary observations warrant further investigation in randomized controlled trials to confirm efficacy and clarify the underlying mechanism.