Apparently adult healthy subjects with possible metabolic risk factors Nutritional, Metabolic, Endocrine
Conditions
Interventions
A healthy and sustainable dietary pattern called MED_EAT-IT has been developed also considering the possibility to make it tailored to individual characteristics (see https://doi.org/10.1016/j.crfs.20
Sponsors
University of Milan
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Healthy adult volunteers (aged >18 years)
Exclusion criteria
Exclusion criteria: 1. Pharmacological therapies that may interfere in the analysis of the results (e.g., antibiotics) 2. Presence of pathologies that may contraindicate adherence to the dietary pattern (e.g., celiac disease, food allergies related to nuts, inflammatory bowel diseases). In case of doubt, the eligibility of the subject will be left to the decision of the medical staff involved in the research 3. Severe obesity or specific diets (e.g., vegetarian, vegan), diets for specific pathologies (e.g. gluten-free diet, low FODMAP diet) 4. Regular use of food supplements 5. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of short-chain fatty acids (SCFA) in biological samples measured by mass spectrometry at the beginning and at the end of each intervention arm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dietary habits are recorded using a 7-day weighted food diary at the beginning, after 4 weeks, and after 8 weeks of each intervention 2. Anthropometric measures and body composition are evaluated using reference methods for height, weight, waist circumferences, and Body Impendence Assessment (BIA) for body composition, at the beginning and at the end of each intervention 3. Markers of nutritional status (e.g., vitamins, minerals, and bioactive compounds) will be evaluated in serum through standardized analytical methods at the beginning and at the end of each intervention 4. Markers of glucose metabolism (e.g., fasting glucose, insulin, HOMA-IR) will be evaluated in serum through standardized analytical methods at the beginning and at the end of each intervention 5. Markers of lipid profile (e.g., total cholesterol, LDL, HDL, triglycerides) will be evaluated in serum through standardized analytical methods at the beginning and at the end of each intervention 6. Markers of inflammatory status (e.g., TNF-a, IL-6, CRP) and oxidative stress (e.g., ox-LDL, DNA damage by Comet assay) will be evaluated in serum, using ELISA kits, at the beginning and at the end of each intervention 7. Microbiota composition in fecal samples will be evaluated through 16S rRNA sequencing methods at the beginning and at the end of each intervention 8. Metabolomic analyses performed on urine samples by mass spectrometry at the beginning and at the end of each intervention 9. Environmental impact, including carbon and water footprints, are assessed based on food intake data collected at the beginning and at the end of each intervention arms using a multilevel database from the EU SU-EATABLE LIFE project 10. The acceptability and feasibility of the MED_EAT-IT dietary pattern are evaluated through validated questionnaires at the end of the treatment Added 04/06/2026: 11. Proteomic analyses performed on serum samples using the SomaScan platform at the beginning and at the end of each intervent | — |
Countries
Italy
Contacts
Public ContactPatrizia Riso
Outcome results
None listed