Prevent and Reverse Obesity in Children, Adolescents and Young Adults

Obesity and overweight are non-communicable diseases with an increasing incidence in children, adolescents, and adults. International efforts to reverse the current epidemiological trend of rising overweight, obesity, and related diseases have so far been insufficient to achieve this goal. Therefore, a change in strategy-both at the individual and public health levels-is urgently needed. Searching the litterature, there are currently no studies employing a comprehensive, personalized, and multi-level strategy to induce stable changes in dietary and lifestyle habits, while also conducting careful follow-up of outcomes and exploring the pathogenic mechanisms affecting metabolic pathways, pro-inflammatory and systemic conditions, and intestinal permeability in overweight and obese patients. Evidence shows the beneficial effects of specific dietary patterns (e.g., the Mediterranean Diet) and a healthy lifestyle in reducing body/organ fat accumulation. However, a comprehensive evaluation of their effects-particularly following personalized strategies and careful follow-up-on the pathogenic mechanisms influencing cardiovascular and metabolic risk, pro-inflammatory status, and intestinal permeability in the medium-to-long term is still lacking.

NCT Number	NCT07035704
Lead Sponsor	piero portincasa Collaborators: University of Bari Aldo Moro, Uppsala University, Fundació Eurecat, ADPD, University of Coimbra, AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO, INSTITUTO POLITECNICO DE VIANA DE CASTELO, Consiglio Nazionale delle Ricerche, Italy, Technical University of Munich, MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH, Martin-Luther-Universität Halle-Wittenberg, THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION, INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK, King's College London
Conditions	Overweight (BMI > 25)
Enrollment	200 participants
Start Date	2025-09-15
Primary Completion	2027-01-30 (estimated)
Study Completion	2027-03-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-25