Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 9:41 AM
Study NCT ID:
NCT07035704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevent and Reverse Obesity in Children, Adolescents and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a 12-month, controlled, randomized, multicenter clinical study with five arms.\n\nThe suggested study design will allow to compare different outcomes in subjects included in each treatment arm.\n\nThe 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.\n\n* 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.\n* Group 2: MeD enriched with mushrooms or other dietary supplements: will receive the MeD personalized plan plus commercial mushrooms or other suppleme'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-20', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory markers', 'timeFrame': 'One year', 'description': 'Assessment of serum inflammatory markers such as Interleukins and cytokines'}, {'measure': 'Gut Microbiota', 'timeFrame': 'one year', 'description': 'Assessment of fecal gut microbiota composition'}], 'primaryOutcomes': [{'measure': 'Weight (Kg)', 'timeFrame': 'one year', 'description': 'The primary outcome is weight loss'}], 'secondaryOutcomes': [{'measure': 'Liver enzymes', 'timeFrame': 'one year', 'description': 'Change in AST, ALT, and GGT'}, {'measure': 'Fasting glucose', 'timeFrame': 'one year', 'description': 'Change in glycemic profile'}, {'measure': 'Lipid profile (TC, TG, LDL, HDL)', 'timeFrame': 'one year', 'description': 'Change in Lipid profile'}, {'measure': 'Abdominal fat storage', 'timeFrame': 'one year', 'description': 'Change in abdominal fat depostion'}, {'measure': 'Liver steatosis', 'timeFrame': 'one year', 'description': 'Assessment of liver fat accumulation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MeD diet, Healthy life, obesity'], 'conditions': ['Overweight (BMI > 25)']}, 'referencesModule': {'references': [{'pmid': '35163038', 'type': 'BACKGROUND', 'citation': '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': '32312770', 'type': 'BACKGROUND', 'citation': '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': '31817104', 'type': 'BACKGROUND', 'citation': "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': '34063068', 'type': 'BACKGROUND', 'citation': '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': '33490935', 'type': 'BACKGROUND', 'citation': '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': '32823983', 'type': 'BACKGROUND', 'citation': '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': '32326636', 'type': 'BACKGROUND', 'citation': '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': '31960952', 'type': 'BACKGROUND', 'citation': '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': '32098159', 'type': 'BACKGROUND', 'citation': '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': '35625660', 'type': 'BACKGROUND', 'citation': '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': '32020441', 'type': 'BACKGROUND', 'citation': "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': '28521687', 'type': 'BACKGROUND', 'citation': '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': '26758061', 'type': 'BACKGROUND', 'citation': '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': '25194180', 'type': 'BACKGROUND', 'citation': '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': '29100895', 'type': 'BACKGROUND', 'citation': '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': '34629256', 'type': 'BACKGROUND', 'citation': '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': '35269779', 'type': 'BACKGROUND', 'citation': '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': '35052763', 'type': 'BACKGROUND', 'citation': "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': '35514242', 'type': 'BACKGROUND', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'https://pasgras.eu/goals-and-impact', 'label': 'PROJECT INFO AND DESCRIPTION'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSearching 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.\n\nEvidence 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.', 'detailedDescription': 'The study will enroll 200 adults overweight or obese patients (balanced by sex) attending the metabolic diseases outpatient clinic.\n\nThe 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.\n\nTherefore, 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.\n\nPrimary 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.\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-55 years old overweight or obese men and women (BMI ≥ 25 kg/m2).\n* Signed informed consent.\n* Have a mobile phone, tablet, or computer with internet access.\n\nExclusion Criteria:\n\n* Waist circumference \\> 150 cm\n* Suffer from diabetes or other disorders of glucose metabolism\n* Suffer from dyslipidemia or other alterations of lipid metabolism (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).\n* Present chronic gastrointestinal problems such as Crohn's disease or irritable bowel syndrome.\n* Present any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases.\n* Have a diagnosed liver disease other than steatotic liver disease.\n* Taking supplements or multivitamin supplements or phototherapeutic products for weight loss that interfere with the study.\n* Have taken antibiotics in the last 30 days.\n* Follow a low-calorie diet and/or pharmacological treatment for weight loss.\n* Being a smoker.\n* Regular alcohol consumption (more than 4 Standard Drink Units (SDU) per day or 28 SDU per week.\n* Have lost more than 3 kg of weight in the last 3 months.\n* Suffering from eating disorders or psychiatric disorders.\n* 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.\n* Be pregnant or intend to become pregnant or be breastfeeding,\n* Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.\n* No or limited access to the Internet."}, 'identificationModule': {'nctId': 'NCT07035704', 'acronym': 'PasGras', 'briefTitle': 'Prevent and Reverse Obesity in Children, Adolescents and Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Bari'}, 'officialTitle': 'De-Risking Metabolic, Environmental and Behavioral Determinants of Obesity in Children, Adolescents and Young Adults', 'orgStudyIdInfo': {'id': 'PasGras 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MeD personalized plan', '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', 'interventionNames': ['Dietary Supplement: MeD enriched with mushrooms', "Dietary Supplement: MeD enriched the Lebanese herbal mixture Za'atar"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MeD in combination with semaglutide', '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 + semaglutinine or compatible treatment', 'interventionNames': ["Dietary Supplement: MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)"]}], 'interventions': [{'name': 'MeD enriched with mushrooms', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive the MeD personalized plan plus commercial mushrooms', 'armGroupLabels': ['MeD personalized plan']}, {'name': "MeD enriched the Lebanese herbal mixture Za'atar", 'type': 'DIETARY_SUPPLEMENT', 'description': "Patients will receive the MeD personalized plan plus natural products/extracts of endemic plants (olive oil, herbs like Lebanese Za'atar).", 'armGroupLabels': ['MeD personalized plan']}, {'name': "MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)", 'type': 'DIETARY_SUPPLEMENT', '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 + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)", 'armGroupLabels': ['MeD in combination with semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Bari', 'country': 'Italy', 'contacts': [{'name': 'Danika Schepis, PhD', 'role': 'CONTACT', 'email': 'danikaschepis@gmail.com', 'phone': '+39-080-5592731'}, {'name': 'Piero Portincasa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UniBa', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Danika Schepis, PhD', 'role': 'CONTACT', 'email': 'danikaschepis@gmail.com', 'phone': '+39-080-5592731'}], 'overallOfficials': [{'name': 'Piero Portincasa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bari Aldo Moro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymised Data will be share ONLY among partners'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'piero portincasa', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bari Aldo Moro', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Fundació Eurecat', 'class': 'OTHER'}, {'name': 'ADPD', 'class': 'UNKNOWN'}, {'name': 'University of Coimbra', 'class': 'OTHER'}, {'name': 'AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO', 'class': 'UNKNOWN'}, {'name': 'INSTITUTO POLITECNICO DE VIANA DE CASTELO', 'class': 'UNKNOWN'}, {'name': 'Consiglio Nazionale delle Ricerche, Italy', 'class': 'UNKNOWN'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH', 'class': 'UNKNOWN'}, {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, {'name': 'THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION', 'class': 'UNKNOWN'}, {'name': 'INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK', 'class': 'UNKNOWN'}, {'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'piero portincasa', 'investigatorAffiliation': 'University of Bari'}}}}