Follow up Study of Varapodio Trial: Effect of Longevity and Fasting Mimicking Diet on Risk Factors Age Correlated and Biomarkers of Aging

A large ongoing randomized, open-label trial aimed at evaluating the effects of two different dietary interventions, FMD and LD, on body composition and cardiovascular (CV) biomarkers in a real word population (NCT05698654) is actually ongoing. This trial started in January 2024 will enrol 501 adult subjects between the ages of 30 and 65: 167 subjects randomized to the FMD arm with a 5-day meal program once every three months for a 6-month period (arm 1); 167 subjects randomized to follow the FMD plus a Longevity Diet program (FMD+LD) for a 6-month period (arm 2); 167 randomized to the control group (arm 3) that will continue their usual diet. On 2024,410, participants were enrolled and randomly assigned to FMD, FMD + LD, or control arm. Although preliminary data demonstrated the beneficial effects of such nutritional plans on body weight, BMI, body composition, and cardiovascular (CV) biomarkers, limited data is available on the long-term effects of these powerful nutritional interventions.

NCT Number	NCT07255300
Lead Sponsor	Fondazione Valter Longo Collaborators: Universita degli Studi di Palermo, University of Calabria, Regione Calabria / Comune Varapodio, European Longevity Institute
Conditions	Fat Mass, Risk Factors Cardiovascular Disease, Epigenetic Aging, Metabolism Changes, Overweight (BMI > 25), Risk Behavior, Obesity (Disorder)
Enrollment	135 participants
Start Date	2025-05-02
Primary Completion	2027-05-02 (estimated)
Study Completion	2027-06-02 (estimated)
Updated on ClinicalTrials.gov	2025-12-01