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NCT Number: NCT07035704

Prevent and Reverse Obesity in Children, Adolescents and Young Adults

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MeD enriched with mushrooms

Dietary Supplement

Patients will receive the MeD personalized plan plus commercial mushrooms

MeD enriched the Lebanese herbal mixture Za'atar

Dietary Supplement

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)

Dietary Supplement

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)

Primary outcomes

  1. Weight (Kg)

    Time frame: one year

    The primary outcome is weight loss

Secondary outcomes

  1. Liver enzymes

    Time frame: one year

    Change in AST, ALT, and GGT

  2. Fasting glucose

    Time frame: one year

    Change in glycemic profile

  3. Lipid profile (TC, TG, LDL, HDL)

    Time frame: one year

    Change in Lipid profile

  4. Abdominal fat storage

    Time frame: one year

    Change in abdominal fat depostion

  5. Liver steatosis

    Time frame: one year

    Assessment of liver fat accumulation

Other outcomes

  1. Inflammatory markers

    Time frame: One year

    Assessment of serum inflammatory markers such as Interleukins and cytokines

  2. Gut Microbiota

    Time frame: one year

    Assessment of fecal gut microbiota composition

Study contacts

Contact information is provided by the study sponsor or research team.

Danika Schepis, PhD

CONTACT

[email protected]

+39-080-5592731

Sponsors and collaborators

Lead sponsor

piero portincasa

Other

Collaborators

  • ADPD
  • AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO
  • Consiglio Nazionale delle Ricerche, Italy
  • Fundació Eurecat
  • INSTITUTO POLITECNICO DE VIANA DE CASTELO
  • INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK
  • King's College London
  • MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH
  • Martin-Luther-Universität Halle-Wittenberg
  • THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION
  • Technical University of Munich
  • University of Bari Aldo Moro
  • University of Coimbra
  • Uppsala University

Registry information

Official study title

De-Risking Metabolic, Environmental and Behavioral Determinants of Obesity in Children, Adolescents and Young Adults

Acronym: PasGras

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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