Overweight (BMI > 25)
Conditions
Keywords
MeD diet, Healthy life, obesity
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.
Interventions
DIETARY_SUPPLEMENTMeD enriched with mushrooms
Patients will receive the MeD personalized plan plus commercial mushrooms
DIETARY_SUPPLEMENTMeD 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_SUPPLEMENTMeD 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)
Sponsors
University of Bari Aldo Moro
Uppsala University
Fundació Eurecat
ADPD
University of Coimbra
AGDCENTRO ASSOCIACAO DE GINASTICA DO CENTRO
INSTITUTO POLITECNICO DE VIANA DE CASTELO
Consiglio Nazionale delle Ricerche, Italy
Technical University of Munich
MEDIAGNOST GESELLSCHAFT FUR FORSCHUNG UND HERSTELLUNG VON DIAGNOSTIKA GMBH
Martin-Luther-Universität Halle-Wittenberg
THE EUROPEAN SOCIETY FOR CLINICAL INVESTIGATION
INSTYTUT BIOLOGII DOSWIADCZALNEJ IM. M. NENCKIEGO POLSKIEJ AKADEMII NAUK
King's College London
piero portincasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This will be a 12-month, controlled, randomized, multicenter clinical study with five arms. The suggested study design will allow to compare different outcomes in subjects included in each treatment arm. The study will involve a total of 250 participants from four different centers in four European countries (Spain, Italy, Sweden, and Portugal). The subjects will be assessed at baseline and monitored for 12 months follow-up. Enrolled subjects will be randomly assigned to one of the following three treatment groups. * Group 1: MeD personalized plan: 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. * Group 2: MeD enriched with mushrooms or other dietary supplements: will receive the MeD personalized plan plus commercial mushrooms or other suppleme
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight (Kg) | one year | The primary outcome is weight loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver enzymes | one year | Change in AST, ALT, and GGT |
| Fasting glucose | one year | Change in glycemic profile |
| Lipid profile (TC, TG, LDL, HDL) | one year | Change in Lipid profile |
| Abdominal fat storage | one year | Change in abdominal fat depostion |
| Liver steatosis | one year | Assessment of liver fat accumulation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers | One year | Assessment of serum inflammatory markers such as Interleukins and cytokines |
| Gut Microbiota | one year | Assessment of fecal gut microbiota composition |
Countries
Italy
Contacts
Primary ContactDanika Schepis, PhD
Outcome results
None listed