Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT07035704
Brief 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. 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.
Study:
NCT07035704
Study Brief:
Protocol Section:
NCT07035704