Prevent and Reverse Obesity in Children, Adolescents and Young Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
Sponsorpiero portincasa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-55 years old overweight or obese men and women (BMI ≥ 25 kg/m2).

Signed informed consent.

Have a mobile phone, tablet, or computer with internet access.

Disqualifiers

Waist circumference > 150 cm

Suffer from diabetes or other disorders of glucose metabolism

Suffer from dyslipidemia or other alterations of lipid metabolism (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).

Present chronic gastrointestinal problems such as Crohn's disease or irritable bowel syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MeD enriched with mushrooms

    Dietary supplement

    Patients will receive the MeD personalized plan plus commercial mushrooms

  • MeD enriched the Lebanese herbal mixture Za'atar

    Dietary supplement

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

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

    Dietary supplement

    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)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MeD personalized planActive comparator 2 interventions
Group B: MeD in combination with semaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weight (Kg)

The primary outcome is weight loss

Time frame
one year

Secondary outcomes

1

Liver enzymes

Change in AST, ALT, and GGT

Time frame
one year
2

Fasting glucose

Change in glycemic profile

Time frame
one year
3

Lipid profile (TC, TG, LDL, HDL)

Change in Lipid profile

Time frame
one year
4

Abdominal fat storage

Change in abdominal fat depostion

Time frame
one year

Other outcomes

1

Inflammatory markers

Assessment of serum inflammatory markers such as Interleukins and cytokines

Time frame
One year
2

Gut Microbiota

Assessment of fecal gut microbiota composition

Time frame
one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

piero portincasa

Lead sponsor

University of Bari

Sponsor institution

University of Bari Aldo Moro

Collaborator

Uppsala University

Collaborator

Fundació Eurecat

Collaborator

ADPD

Collaborator

University of Coimbra

Collaborator

AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO

Collaborator

INSTITUTO POLITECNICO DE VIANA DE CASTELO

Collaborator

Consiglio Nazionale delle Ricerche, Italy

Collaborator

Technical University of Munich

Collaborator

MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH

Collaborator

Martin-Luther-Universität Halle-Wittenberg

Collaborator

THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION

Collaborator

INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK

Collaborator

King's College London

Collaborator

This trial is not recruiting at the moment. You can still explore other options: