Prevent and Reverse Obesity in Children, Adolescents and Young Adults

NCT07035704 · tracked via the Priya Life Science Italy tracker

Sponsor

piero portincasa

Phase

Not applicable

Started

2025-09-15

Last updated

2025-06-25

Condition(s) studied

Overweight (BMI > 25)

Investigational drug(s) / intervention(s)

MeD enriched with mushroomsMeD enriched the Lebanese herbal mixture Za'atarMeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)

MeD enriched with mushrooms: Patients will receive the MeD personalized plan plus commercial mushrooms

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).

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)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Present any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases. * Have a diagnosed liver disease other than steatotic liver disease. * Taking supplements or multivitamin supplements or phototherapeutic products for weight loss that interfere with the study. * Have taken antibiotics in the last 30 days. * Follow a low-calorie diet and/or pharmacological treatment for weight loss. * Being a smoker. * Regular alcohol consumption (more than 4 Standard Drink Units (SDU) per day or 28 SDU per week. * Have lost more than 3 kg of weight in the last 3 months. * Suffering from eating disorders or psychiatric disorders. * Present food intolerances and/or allergies related to the study products, such as allergy to edible mushrooms or fungal spores or to any of the components of the Lebanese herbal mixture Za'atar such as sesame seeds. * Be pregnant or intend to become pregnant or be breastfeeding, * Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study. * No or limited access to the Internet.

Primary outcome measure(s)

Weight (Kg) — one year
The primary outcome is weight loss

Trial sites (1)

Facility	City	Region	Status
UniBa	Bari	Bari

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035704 on ClinicalTrials.gov ↗ ← All trials in Italy