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Antonio Muscari,1 Paola Forti,1,2 Mara Brizi,2 Donatella Magalotti,2 Eleonora Capelli,2 Simona Potì,2 Filomena Piro,3 Paolo Pandolfi,4 Vincenza Perlangeli,4 Eric Ramazzotti,5 Giovanni Barbara1,2 On behalf of PBAR Study Group1Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; 2Medical-Surgical Department of Digestive, Hepatic and Endocrine-Metabolic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 3Pharmaceutical Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 4Epidemiological and Health Promotion Unit, Department of Public Health, AUSL Bologna, Bologna, Italy; 5LUM Metropolitan Laboratory, AUSL Bologna, Bologna, ItalyCorrespondence: Antonio Muscari, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, Via Albertoni, 15, Bologna, 40138, Italy, Tel +39-347-1126386, Fax +39-051-6362210, Email antonio.muscari@unibo.itPurpose: The availability of a simple and reliable marker of biological age might allow an acceleration of the research in the field of longevity extension. Previous studies suggest that this marker might be the N-terminal of B-type natriuretic peptide precursor (NT-proBNP), from which proBNPage, a biological age surrogate, can be calculated. Objectives of the study: 1) To fine-tune the method of proBNPage progression assessment and 2) To establish whether 4 “anti-aging” treatments, which provided promising results in previous studies, can modify proBNPage progression.Patients and Methods: This is a double-blind randomized placebo-controlled clinical trial on 120 adults aged 65– 80 years, free of cardiovascular diseases. Participants will be randomized into 3 groups: A) Coenzyme Q10 100 mg bid + Selenium 100 mcg; B) Resveratrol 350 mg bid + TA-65 (Astragalus Membranaceus extract) 100U; C) Placebo-1 bid + Placebo-2. They will be followed for 2 years and checked 8 times, to assess both proBNPage progression and treatment safety. Secondary variables (handgrip strength, aerobic capacity at the step test and quality of life) will also be assessed. Primary outcome will be the demonstration of significant changes of proBNPage, compared to baseline, in the 3 groups at 6, 12, 18 and 24 months. Secondary outcome will be the demonstration of similar changes of secondary variables. Statistical analyses will be mainly performed by repeated measures ANOVA (both according to intention to treat and per protocol) and paired t tests. The study was approved by the Ethics Committee Area Vasta Emilia Centro, Emilia-Romagna Region, ID: 64/2022/Sper/AOUBo. Trial registration: ClinicalTrials.gov, NCT05500742.Conclusion: The use of proBNPage as a surrogate of biological age may prove an easy method to select anti-aging treatments worthy of further, more complex assessments.Keywords: anti-aging treatments, biological age, food supplements, longevity, NT-proBNP, study protocol, randomized clinical trial |
