Prevent and Reverse Obesity in Children, Adolescents and Young Adults

Not Applicable

Not yet recruiting

• Conditions: Overweight (BMI > 25)

• Registration Number: NCT07035704
• Lead Sponsor: piero portincasa

Brief 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.

Detailed Description

The study will enroll 200 adults overweight or obese patients (balanced by sex) attending the metabolic diseases outpatient clinic.

The MeD effects on the reduction of cardiometabolic risk in overweight and obese individuals originate beyond the nutritional component. The combination of personalized dietary and lifestyle treatments in the MeD setting can result in a greater strategy to reduce overweight, obesity and related cardiometabolic risk factors than the MeD alone.

Therefore, in the present study reaserchers hypothesize that the MeD associated with personalized dietary, lifestyle, and therapeutic strategies, including digital tools, a physical activity program, and under-explored MeD components such as mushrooms and the Lebanese herbal mixture "Za'atar", can increase the diet efficacy in tackling overweight and obesity.

Primary Objective: To identify and validate personalized interventions (tailored to individual risk) aimed at reducing health risks associated with overweight and obesity by targeting environmental, socio-cultural, and metabolic health determinants responsible for fat accumulation and related systemic diseases.

Secondary Objectives: To evaluate the nutritional and functional benefits of personalized dietary/lifestyle strategies on pathogenic factors influencing metabolic and pro-inflammatory status and intestinal permeability.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-09-15
• Primary Completion: 2027-01-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight (Kg)	one year	The primary outcome is weight loss

Secondary Outcome Measures

Name	Time	Method
Liver enzymes	one year	Change in AST, ALT, and GGT
Fasting glucose	one year	Change in glycemic profile
Lipid profile (TC, TG, LDL, HDL)	one year	Change in Lipid profile
Abdominal fat storage	one year	Change in abdominal fat depostion
Liver steatosis	one year	Assessment of liver fat accumulation

Trial Locations

Locations (1)

UniBa; 🇮🇹 Bari, Italy