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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
MeD enriched with mushrooms
Dietary supplementPatients will receive the MeD personalized plan plus commercial mushrooms
MeD enriched the Lebanese herbal mixture Za'atar
Dietary supplementPatients 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 supplementPatients 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
Trial outcomes
Primary outcomes
Weight (Kg)
The primary outcome is weight loss
Secondary outcomes
Liver enzymes
Change in AST, ALT, and GGT
Fasting glucose
Change in glycemic profile
Lipid profile (TC, TG, LDL, HDL)
Change in Lipid profile
Abdominal fat storage
Change in abdominal fat depostion
Other outcomes
Inflammatory markers
Assessment of serum inflammatory markers such as Interleukins and cytokines
Gut Microbiota
Assessment of fecal gut microbiota composition
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
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