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Prevent and Reverse Obesity in Children, Adolescents and Young Adults (PasGras) 200 Internacional Adolescente Estilo de vida Dieta

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O estudo clínico NCT07035704 (PasGras) é um estudo intervencionista para Overweight (BMI > 25). Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 15 de setembro de 2025, com o objetivo de incluir 200 participantes. Coordenado por piero portincasa e deve ser concluído em 30 de março de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de junho de 2025.
Resumo
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.

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Descrição detalhada
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...

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Título oficial

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

Condições médicas
Overweight (BMI > 25)
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
Outros IDs do estudo
  • PasGras
  • PasGras 2025
Número NCT
NCT07035704
Data de início (real)
2025-09-15
Última atualização postada
2025-06-25
Data de conclusão (estimada)
2027-03-30
Inscrição (estimada)
200
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
MeD diet, Healthy life, obesity
Propósito principal
Outro
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador ativoMeD personalized plan
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
MeD enriched with mushrooms
Patients will receive the MeD personalized plan plus commercial mushrooms
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).
Comparador ativoMeD in combination with semaglutide
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
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)
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Weight (Kg)
The primary outcome is weight loss
one year
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Liver enzymes
Change in AST, ALT, and GGT
one year
Fasting glucose
Change in glycemic profile
one year
Lipid profile (TC, TG, LDL, HDL)
Change in Lipid profile
one year
Abdominal fat storage
Change in abdominal fat depostion
one year
Liver steatosis
Assessment of liver fat accumulation
one year
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
  • 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.

  • 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.
piero portincasa logopiero portincasa
Responsável pelo estudo
piero portincasa, Patrocinador-Investigador, Professor, University of Bari
Contato central do estudo
Contato: Danika Schepis, PhD, +39-080-5592731, [email protected]
1 Locais do estudo em 1 países

Bari

UniBa, Bari, Bari, 70124, Italy
Danika Schepis, PhD, Contato, +39-080-5592731, [email protected]
Piero Portincasa, PhD, Investigador principal