De-Risking Metabolic, Environmental and Behavioral Determinants of Obesity in Children, Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Weight (Kg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MeD 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
干预措施: MeD enriched with mushrooms (Dietary Supplement)
MeD 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
干预措施: MeD enriched the Lebanese herbal mixture Za'atar (Dietary Supplement)
MeD 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
干预措施: MeD Diet + semaglutinine or compatible treatment+ Za'atar or Mushroom (to be defined) (Dietary Supplement)
结局指标
主要结局
Weight (Kg)
时间窗: one year
The primary outcome is weight loss
次要结局
- Liver enzymes(one year)
- Fasting glucose(one year)
- Lipid profile (TC, TG, LDL, HDL)(one year)
- Abdominal fat storage(one year)
- Liver steatosis(one year)
研究者
piero portincasa
Professor
University of Bari