Prevent and Reverse Obesity in Children, Adolescents and Young Adults

NCT07035704 | Not Yet Recruiting DMC

• 1 other identifier: PasGras 2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight (BMI > 25)

Keywords

MeD diet, Healthy life, obesity

Outcome Measures

Primary Outcomes (1)

• Weight (Kg)

  The primary outcome is weight loss

  one year

Secondary Outcomes (5)

• Liver enzymes

  one year

• Fasting glucose

  one year

• Lipid profile (TC, TG, LDL, HDL)

  one year

• Abdominal fat storage

  one year

• Liver steatosis

  one year

Other Outcomes (2)

• Inflammatory markers

  One year

• Gut Microbiota

  one year

Study Arms (2)

MeD personalized plan

ACTIVE COMPARATOR

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

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

MeD in combination with semaglutide

ACTIVE COMPARATOR

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

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

Interventions

MeD enriched with mushrooms DIETARY_SUPPLEMENT

Patients will receive the MeD personalized plan plus commercial mushrooms

MeD personalized plan

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 personalized plan

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)

MeD in combination with semaglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

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

Study Sites (1)

UniBa

Bari, Bari, 70124, Italy

Location

Related Publications (19)

• Portincasa P, Bonfrate L, Vacca M, De Angelis M, Farella I, Lanza E, Khalil M, Wang DQ, Sperandio M, Di Ciaula A. Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis. Int J Mol Sci. 2022 Jan 20;23(3):1105. doi: 10.3390/ijms23031105.

  PMID: 35163038 BACKGROUND

• Van Gorp H, Huang L, Saavedra P, Vuylsteke M, Asaoka T, Prencipe G, Insalaco A, Ogunjimi B, Jeyaratnam J, Cataldo I, Jacques P, Vermaelen K, Dullaers M, Joos R, Sabato V, Stella A, Frenkel J, De Benedetti F, Dehoorne J, Haerynck F, Calamita G, Portincasa P, Lamkanfi M. Blood-based test for diagnosis and functional subtyping of familial Mediterranean fever. Ann Rheum Dis. 2020 Jul;79(7):960-968. doi: 10.1136/annrheumdis-2019-216701. Epub 2020 Apr 20.

  PMID: 32312770 BACKGROUND

• Rizzello CG, Portincasa P, Montemurro M, Di Palo DM, Lorusso MP, De Angelis M, Bonfrate L, Genot B, Gobbetti M. Sourdough Fermented Breads are More Digestible than Those Started with Baker's Yeast Alone: An In Vivo Challenge Dissecting Distinct Gastrointestinal Responses. Nutrients. 2019 Dec 4;11(12):2954. doi: 10.3390/nu11122954.

  PMID: 31817104 BACKGROUND

• Cosola C, Rocchetti MT, di Bari I, Acquaviva PM, Maranzano V, Corciulo S, Di Ciaula A, Di Palo DM, La Forgia FM, Fontana S, De Angelis M, Portincasa P, Gesualdo L. An Innovative Synbiotic Formulation Decreases Free Serum Indoxyl Sulfate, Small Intestine Permeability and Ameliorates Gastrointestinal Symptoms in a Randomized Pilot Trial in Stage IIIb-IV CKD Patients. Toxins (Basel). 2021 May 5;13(5):334. doi: 10.3390/toxins13050334.

  PMID: 34063068 BACKGROUND

• Molina-Molina E, Shanmugam H, Di Ciaula A, Grattagliano I, Di Palo DM, Palmieri VO, Portincasa P. (13C)-Methacetin breath test provides evidence of subclinical liver dysfunction linked to fat storage but not lifestyle. JHEP Rep. 2020 Nov 4;3(1):100203. doi: 10.1016/j.jhepr.2020.100203. eCollection 2021 Feb.

  PMID: 33490935 BACKGROUND

• Di Ciaula A, Baj J, Garruti G, Celano G, De Angelis M, Wang HH, Di Palo DM, Bonfrate L, Wang DQ, Portincasa P. Liver Steatosis, Gut-Liver Axis, Microbiome and Environmental Factors. A Never-Ending Bidirectional Cross-Talk. J Clin Med. 2020 Aug 14;9(8):2648. doi: 10.3390/jcm9082648.

  PMID: 32823983 BACKGROUND

• Vacca M, Celano G, Calabrese FM, Portincasa P, Gobbetti M, De Angelis M. The Controversial Role of Human Gut Lachnospiraceae. Microorganisms. 2020 Apr 15;8(4):573. doi: 10.3390/microorganisms8040573.

  PMID: 32326636 BACKGROUND

• Bonfrate L, Di Palo DM, Celano G, Albert A, Vitellio P, De Angelis M, Gobbetti M, Portincasa P. Effects of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 in IBS patients. Eur J Clin Invest. 2020 Mar;50(3):e13201. doi: 10.1111/eci.13201. Epub 2020 Feb 12.

  PMID: 31960952 BACKGROUND

• Di Palo DM, Garruti G, Di Ciaula A, Molina-Molina E, Shanmugam H, De Angelis M, Portincasa P. Increased Colonic Permeability and Lifestyles as Contributing Factors to Obesity and Liver Steatosis. Nutrients. 2020 Feb 21;12(2):564. doi: 10.3390/nu12020564.

  PMID: 32098159 BACKGROUND

• Baldini F, Khalil M, Bartolozzi A, Vassalli M, Di Ciaula A, Portincasa P, Vergani L. Relationship between Liver Stiffness and Steatosis in Obesity Conditions: In Vivo and In Vitro Studies. Biomolecules. 2022 May 23;12(5):733. doi: 10.3390/biom12050733.

  PMID: 35625660 BACKGROUND

• Faienza MF, Chiarito M, Molina-Molina E, Shanmugam H, Lammert F, Krawczyk M, D'Amato G, Portincasa P. Childhood obesity, cardiovascular and liver health: a growing epidemic with age. World J Pediatr. 2020 Oct;16(5):438-445. doi: 10.1007/s12519-020-00341-9. Epub 2020 Feb 4.

  PMID: 32020441 BACKGROUND

• Di Ciaula A, Portincasa P. Diet and Contaminants: Driving the Rise to Obesity Epidemics? Curr Med Chem. 2019;26(19):3471-3482. doi: 10.2174/0929867324666170518095736.

  PMID: 28521687 BACKGROUND

• Faienza MF, Wang DQ, Fruhbeck G, Garruti G, Portincasa P. The dangerous link between childhood and adulthood predictors of obesity and metabolic syndrome. Intern Emerg Med. 2016 Mar;11(2):175-82. doi: 10.1007/s11739-015-1382-6. Epub 2016 Jan 12.

  PMID: 26758061 BACKGROUND

• Bonfrate L, Wang DQ, Garruti G, Portincasa P. Obesity and the risk and prognosis of gallstone disease and pancreatitis. Best Pract Res Clin Gastroenterol. 2014 Aug;28(4):623-35. doi: 10.1016/j.bpg.2014.07.013. Epub 2014 Jul 22.

  PMID: 25194180 BACKGROUND

• Vecchie A, Dallegri F, Carbone F, Bonaventura A, Liberale L, Portincasa P, Fruhbeck G, Montecucco F. Obesity phenotypes and their paradoxical association with cardiovascular diseases. Eur J Intern Med. 2018 Feb;48:6-17. doi: 10.1016/j.ejim.2017.10.020.

  PMID: 29100895 BACKGROUND

• Baldini F, Khalil M, Serale N, Voci A, Portincasa P, Vergani L. Extent and features of liver steatosis in vitro pave the way to endothelial dysfunction without physical cell-to-cell contact. Nutr Metab Cardiovasc Dis. 2021 Nov 29;31(12):3522-3532. doi: 10.1016/j.numecd.2021.08.032. Epub 2021 Aug 13.

  PMID: 34629256 BACKGROUND

• Di Ciaula A, Bonfrate L, Krawczyk M, Fruhbeck G, Portincasa P. Synergistic and Detrimental Effects of Alcohol Intake on Progression of Liver Steatosis. Int J Mol Sci. 2022 Feb 27;23(5):2636. doi: 10.3390/ijms23052636.

  PMID: 35269779 BACKGROUND

• Portincasa P, Bonfrate L, Khalil M, Angelis M, Calabrese FM, D'Amato M, Wang DQ, Di Ciaula A. Intestinal Barrier and Permeability in Health, Obesity and NAFLD. Biomedicines. 2021 Dec 31;10(1):83. doi: 10.3390/biomedicines10010083.

  PMID: 35052763 BACKGROUND

• Yarnoz-Esquiroz P, Olazaran L, Aguas-Ayesa M, Perdomo CM, Garcia-Goni M, Silva C, Fernandez-Formoso JA, Escalada J, Montecucco F, Portincasa P, Fruhbeck G. 'Obesities': Position statement on a complex disease entity with multifaceted drivers. Eur J Clin Invest. 2022 Jul;52(7):e13811. doi: 10.1111/eci.13811. Epub 2022 May 12.

  PMID: 35514242 BACKGROUND

Related Links

• PROJECT INFO AND DESCRIPTION

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Piero Portincasa, PhD

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danika Schepis, PhD

CONTACT

+39-080-5592731; danikaschepis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This will be a 12-month, controlled, randomized, multicenter clinical study with five arms. The suggested study design will allow to compare different outcomes in subjects included in each treatment arm. The study will involve a total of 250 participants from four different centers in four European countries (Spain, Italy, Sweden, and Portugal). The subjects will be assessed at baseline and monitored for 12 months follow-up. Enrolled subjects will be randomly assigned to one of the following three treatment groups. * Group 1: MeD personalized plan: 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. * Group 2: MeD enriched with mushrooms or other dietary supplements: will receive the MeD personalized plan plus commercial mushrooms or other suppleme

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 25, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)