NCT07035704Not yet recruiting
Prevent and Reverse Obesity in Children, Adolescents and Young Adults
De-Risking Metabolic, Environmental and Behavioral Determinants of Obesity in Children, Adolescents and Young Adults
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- piero portincasa
- Diseases
- Obesity
- NCT number
- NCT07035704
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 15 Sept 2025 to the primary completion date, 30 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
Other illness
- 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.
- 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.
Lab values
- 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).
Other
- Waist circumference \> 150 cm
- 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.
- Be pregnant or intend to become pregnant or be breastfeeding,
- No or limited access to the Internet.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UniBa Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.