Prevent and Reverse Obesity in Children, Adolescents and Young Adults (PasGras)

piero portincasa

Status

Begins enrollment in 2 months

Conditions

Overweight (BMI > 25)

Treatments

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

Dietary Supplement: MeD enriched the Lebanese herbal mixture Za'atar

Dietary Supplement: MeD enriched with mushrooms

Study type

Interventional

Funder types

Other

Identifiers

NCT07035704

PasGras 2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

MeD personalized plan

Active Comparator group

Description:

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