Investigating the Effects of Monarda Didyma L. Extract Supplementation on Biological Aging of Susceptible Population: Protocol of a Randomized, Placebo- Controlled, Double-blind Parallel Clinical Trial

Abstract

Abstract Background Manipulations to decelerate biological aging and extend health span are major challenges for health given the social and healthcare costs of aging population. Excessive oxidative stress and inflammation are primary drivers in biological aging and age-related diseases. Didymin, a natural bioactive flavonoid and the major polyphenol of Monarda didyma L., has showed a crucial anti-inflammatory role. This clinical study aims to investigate the potential benefits of a 12-weeks supplementation of Monarda didyma L. extract on reducing / delaying the biological aging of a susceptible population of aging workers. Methods This is a randomized, placebo-controlled, double-blind, parallel design and monocentric clinical trial. Study population will comprise 80 participants, aged 45–65 years, randomly allocated to both Intervention group (supplementation of Monarda didyma L. extract) and placebo control group (placebo supplementation) for a 12-weeks period of treatment. All study participants, who will be enrolled at the Occupational Medicine Unit – Azienda Ospedale Università of Padova providing a written informed consent, will undergo clinical examination, an interview with structured questionnaires (demographic data, lifestyle, information quality of life and sleeping patterns) and collection of fasting blood for evaluation of indicators of biological aging as primary outcomes (DNA methylation age, telomere length, mitochondrial DNA copy number), as well as secondary outcomes including basic biochemistry and inflammation markers (emocrome, glycemia, insulin, total cholesterol, low and high density lipoproteins, triglycerides, creatinine, telomerase expression, C-reactive protein, interleukin6, aspartate transaminase, alanine transaminase, gamma-glutamyl transferase) and salivary sample for cortisol analysis. Clinical examination and sample collection, to assess primary and secondary outcomes, will be performed at enrollment and at the follow up after of this treatment. Tracking of additional parameters (heart rate, sleep, mobility) will be performed along the study period by using a wearable MiBand 7 watch and a daily diary to determine compliance and record effects on stress, well-being and health status. Discussion The success of this research could represent a turning point in the healthy aging research, leading to rejuvenation by means of a sustainable and safe intervention, accessible to everybody in order to extend health span. Trial registration: ClinicalTrials.gov PRS (NCT05399966), registration date: May 17, 2022.