Overweight (BMI > 25)PasGrasNCT07035704
Prevent and Reverse Obesity in Children, Adolescents and Young Adults
A study testing MeD enriched with mushrooms, MeD enriched the Lebanese herbal mixture Za'atar and MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined) in people with Overweight (BMI > 25), run by piero portincasa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight (BMI > 25)
- What is being tested?
- MeD enriched with mushrooms, MeD enriched the Lebanese herbal mixture Za'atar and MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 30 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
UniBa
Bari, Bari, 70124
Danika Schepis, PhD, +39-080-5592731, danikaschepis@gmail.com
Piero Portincasa, PhD
About this study
Official title: De-Risking Metabolic, Environmental and Behavioral Determinants of 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.
Read the 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.
- Conditions
- Overweight (BMI > 25)
- Being tested
- MeD enriched with mushrooms, MeD enriched the Lebanese herbal mixture Za'atar, MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)
- Keywords
- MeD diet, Healthy life, obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeD enriched with mushroomsDietary supplement
Patients will receive the MeD personalized plan plus commercial mushrooms
MeD enriched the Lebanese herbal mixture Za'atarDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (Kg)
The primary outcome is weight loss
Measured: one year
Secondary outcomes (5)
Liver enzymes
Change in AST, ALT, and GGT
Measured: one year
Fasting glucose
Change in glycemic profile
Measured: one year
Lipid profile (TC, TG, LDL, HDL)
Change in Lipid profile
Measured: one year
Abdominal fat storage
Change in abdominal fat depostion
Measured: one year
Liver steatosis
Assessment of liver fat accumulation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- piero portincasa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro, Uppsala University, Fundació Eurecat, ADPD, University of Coimbra, AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO, INSTITUTO POLITECNICO DE VIANA DE CASTELO, Consiglio Nazionale delle Ricerche, Italy, Technical University of Munich, MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH, Martin-Luther-Universität Halle-Wittenberg, THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION, INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK, King's College London
- Responsible party
- Sponsor-investigator, piero portincasa, University of Bari
- Investigators
- Piero Portincasa, PhD, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035704
- Sponsor's protocol ID
- PasGras 2025
- Acronym
- PasGras
- Status last verified
- Dec 2024
- First submitted
- 10 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised Data will be share ONLY among partners
Publications
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.
PubMed 35163038Van 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.
PubMed 32312770Rizzello 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.
PubMed 31817104Cosola 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.
PubMed 34063068Molina-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.
PubMed 33490935Di 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.
PubMed 32823983Vacca 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.
PubMed 32326636Bonfrate 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.
PubMed 31960952Di 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.
PubMed 32098159Baldini 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.
PubMed 35625660Faienza 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.
PubMed 32020441Di 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.
PubMed 28521687Faienza 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.
PubMed 26758061Bonfrate 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.
PubMed 25194180Vecchie 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.
PubMed 29100895