Prevent and Reverse Obesity in Children, Adolescents and Young Adults

Official title

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

Overview

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.

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.

Interventions

• Dietary supplement MeD enriched with mushrooms
  Patients will receive the MeD personalized plan plus commercial mushrooms
• Dietary supplement MeD enriched the Lebanese herbal mixture Za'atar
  Patients will receive the MeD personalized plan plus natural products/extracts of endemic plants (olive oil, herbs like Lebanese Za'atar).
• Dietary supplement MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined)
  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 outcome measures

• Weight (Kg) [Time frame: one year]

Secondary outcome measures (5)

• Liver enzymes [Time frame: one year]
• Fasting glucose [Time frame: one year]
• Lipid profile (TC, TG, LDL, HDL) [Time frame: one year]
• Abdominal fat storage [Time frame: one year]
• Liver steatosis [Time frame: one year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Italy · 1 center

• UniBa — Bari

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. PMID 35163038
• 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. do PMID 32312770
• 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
• 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) PMID 34063068
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07035704 · PasGras 2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗