Prevent and Reverse Obesity in Children, Adolescents and Young Adults

Summary

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.

Conditions

• Overweight (BMI > 25)

Interventions

DIETARY_SUPPLEMENT

MeD enriched with mushrooms

Patients will receive the MeD personalized plan plus commercial mushrooms

DIETARY_SUPPLEMENT

MeD enriched the Lebanese herbal mixture Za'atar

Patients will receive the MeD personalized plan plus natural products/extracts of endemic plants (olive oil, herbs like Lebanese Za'atar).

DIETARY_SUPPLEMENT

MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)

Patients will receive counselling and personalized dietary strategy aimed at increasing the adherence to Mediterranean diet by means of use of visual communication (e.g., comics, cartoons, videos) and digital tools (i.e., games, apps), including a physical activity program with a personal trainer + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)

Sponsors & Collaborators

• University of Bari Aldo Moro

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• Fundació Eurecat

  collaborator OTHER

• ADPD

  collaborator UNKNOWN

• University of Coimbra

  collaborator OTHER

• AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO

  collaborator UNKNOWN

• INSTITUTO POLITECNICO DE VIANA DE CASTELO

  collaborator UNKNOWN

• Consiglio Nazionale delle Ricerche, Italy

  collaborator UNKNOWN

• Technical University of Munich

  collaborator OTHER

• MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH

  collaborator UNKNOWN

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION

  collaborator UNKNOWN

• INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK

  collaborator UNKNOWN

• King's College London

  collaborator OTHER

• piero portincasa

  lead OTHER

Principal Investigators

• Piero Portincasa, PhD · University of Bari Aldo Moro

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-15

Primary Completion

2027-01-30

Completion

2027-03-30

Countries

• Italy

Study Locations