Addressing the physiopathology of periodontitis in older adults using an oleuropein-rich olive leaf supplement: Study design and baseline characteristics of the OLIVAGING clinical trial

Background Clinical trials are essential for assessing the efficacy and safety of new therapeutic strategies. This study describes the design and baseline characteristics of the OLIVAGING trial, which evaluates the effects of an olive leaf extract (OLE) enriched in oleuropein in older adults with periodontitis. Methods OLIVAGING is a randomized, double-blind, parallel-group, multicenter clinical trial. Sixty participants with age-related periodontitis were randomized 1:1 to receive either OLE or placebo for 16 weeks. All participants underwent comprehensive periodontal treatment and received standardized oral hygiene instructions. Measurements and biological samples were collected at baseline and after follow-up. Results A total of 46 participants completed the intervention. The mean age was 61.7 ± 9.2 years. Most participants presented overweight or central obesity and elevated blood pressure. Men showed more severe periodontal involvement compared to women. These baseline data indicate a metabolically vulnerable cohort. Conclusions The baseline characteristics support the relevance of evaluating OLE as a nutritional strategy in older adults with periodontitis. The results of this trial may contribute to improving current therapeutic approaches to this prevalent inflammatory condition. Trial registration: ClinicalTrials.gov Identifier: NCT05482373. Registered at: https://clinicaltrials.gov/ct2/show/NCT05482373 .