Beneficial Effects of Dietary and Lifestyle Change in Overweight and Obese Subjects (Healthy-MET)
1. juli 2022 oppdatert av: piero portincasa, University of Bari
Effects of Personalized Dietary and Lifestyle Treatments on the Reduction of Cardiovascular and Metabolic Risk in Overweight and Obese Patients
Obesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults.
In 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (WHO).
In the EU-27 (Eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese.
The growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes).
A transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
The study is aimed to measure the beneficial effects of specific dietary models (i.e., Mediterranean Diet) and healthy lifestyle (i.e., controlled physical activity) in reducing body/organ fat accumulation and in the improvement of metabolic health. A comprehensive and combined analysis of these effects (mainly following personalized strategies and close follow-up) on pathogenic mechanisms affecting cardiovascular and metabolic risk, pro-inflammatory status and intestinal permeability in the medium-long term is still lacking.
During the study, overweight/obese subjects (i.e. Body Mass Index equal or higher to 25Kg/m2) will be assessed at basal and monitored during a 24 months follow-up
Studietype
Observasjonsmessig
Registrering (Forventet)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Piero Portincasa
- Telefonnummer: +39-080-5592731
- E-post: piero.portincasa@uniba.it
Studiesteder
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BA
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Bari, BA, Italia, 70124
- Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Enrolled in the study will be 200 overweight or obese adult patients (comparable sex ratio) entering the outpatient clinic for metabolic diseases.
Subjects will be randomized in two groups (i.e., n=100 treated and n=100 controls). For an unpaired t-test (i.e., comparison of two groups), 50 is the minimum sample size needed in each group to obtain a power of 0.80, when the effect size is medium and a significance level of 0.05 is employed.
Beskrivelse
Inclusion Criteria:
- overweight or obese patients
- patients who able to sign informed consent
Exclusion Criteria:
- failure to sign informed consent;
- inclusion in other research protocols
- Normal weight patients
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Treated
Counselling, personalized dietary strategy aimed at increasing the adherence to Mediterranean diet, personalized physical activity program with a personal trainer, use of digital tools (i.e., games, apps) aimed at improving the adherence to dietary/lifestyle indications.
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Control
generic dietary indications oriented to weight reduction; generic invitations to increase physical activity, routine monitoring
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Effects of treatments on Body Mass Index and waist circumference
Tidsramme: 24 months
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waist circumference will be measured and expressed in cm.
weight and height will be combined to report BMI in kg/m^2.
Measurements will be taken at enrollment and during follow-up.
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24 months
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Effects of treatments on visceral fat
Tidsramme: 24 months
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Measurement of visceral fat by ultrasonography (expressed in mm) will be performed at baseline and during follow-up
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24 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in metabolic indices and in hormones involved in the regulation of glucose metabolism
Tidsramme: 24 months
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gluco-lipid profile, adipokines, insulinemia, HOMA index will be measured at baseline and during the follow-up
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24 months
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Change in hormones involved in nutrient sensing
Tidsramme: 24 months
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GLP-1, GIP, total and acylated ghrelin, PYY will be measured at baseline and during the follow-up
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24 months
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Effects of microbiota and metabolome
Tidsramme: 24 months
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profiling of gut microbiota and assessment of metabolome will be assessed in enrolled subjects at baseline and during follow-up
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24 months
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Effects on intestinal permeability
Tidsramme: 24 months
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markers of intestinal permeability (blood / urine dosage of LPS, zonulin) urinary dosage of sugars with selective gastrointestinal absorption, aimed at evaluating intestinal permeability at the gastric, ileal and colic level.
Assessments will be performed at baseline and during the follow-up
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24 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Vitellio P, Celano G, Bonfrate L, Gobbetti M, Portincasa P, De Angelis M. Effects of Bifidobacterium longum and Lactobacillus rhamnosus on Gut Microbiota in Patients with Lactose Intolerance and Persisting Functional Gastrointestinal Symptoms: A Randomised, Double-Blind, Cross-Over Study. Nutrients. 2019 Apr 19;11(4):886. doi: 10.3390/nu11040886.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. januar 2023
Primær fullføring (Forventet)
1. januar 2025
Studiet fullført (Forventet)
1. juni 2025
Datoer for studieregistrering
Først innsendt
22. juni 2022
Først innsendt som oppfylte QC-kriteriene
1. juli 2022
Først lagt ut (Faktiske)
7. juli 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HEALTHYMET01-2022
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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