Overweight and low adherence to the Mediterranean Diet Nutritional, Metabolic, Endocrine
Conditions
Interventions
The following multicentric study involves 120 volunteers (40 subjects for each research centre). Volunteers will be enrolled and randomized based on a computer randomization plan:
1. M
Sponsors
Ministry of Education, Universities and Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 30 - 60 years old 2. BMI 25 - 29.9 kg/m² 3. Low adherence (score = 5) to the Mediterranean diet
Exclusion criteria
Exclusion criteria: 1. Obesity (BMI 30 kg/m²) 2. Diabetes, dysthyroidism 3. Chronic constipation, diarrhea or any other gut disease 4. Liver, kidney or other diseases 5. Known food allergies 6. Regular use of medications, dietary supplement 7. Consumption of antibiotics in the previous 3 months 8. Specific diet such as vegan or macrobiotic 9. Pregnancy/lactation 10. SARS-CoV-2 infection diagnosed by molecular diagnostic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Prevotella relative amount analysed by high-throughput rRNA gene-targeted amplicon sequencing and short-chain fatty acids (SCFAs), urinary and fecal ferulic acid analysed by GC-MS and 1H-NMR at time zero and after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gut microbiota quantified by a metagenomic approach based on amplicon sequencing ar time zero and after 8 weeks 2. Host-microbe interactions: fecal samples will be treated to safely separate the microbial cells, which will be allowed interact with HT29 cells and the inflammatory activity will be assessed by RT-PCR and ELISA at time zero and after 8 weeks 3. Identification and estimation of gut metabolome in fecal samples by GC-MS and 1H-NMR at time zero and after 8 weeks 4. Shotgun meta-genomics will be carried out on all the fecal samples collected. Meta-proteomics analyses will be performed in a subset of fecal samples. Fecal microorganisms will be recovered and lysed with the aim to identify peptides. The analysis will be performed by gel-free proteomic platforms at time zero and after 8 weeks 5. Inflammatory markers, e.g., C-reactive protein (PCR), interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-a), analysed by ELISA kit at time zero and after 8 weeks 6. Oxidative stress markers (e.g. endogenous and oxidatively induced DNA damage) analysed in blood by comet assay at time zero and after 8 weeks 7. Metabolic and functional markers (e.g., glycemia, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, liver and renal function) assessed by a standardized validated protocol using an automatic biochemical analyser at time zero and time 8 weeks 8. Anthropometric measurements assessed by following international guidelines at time zero and time 8 weeks 9. Blood pressure measured by determining both systolic and diastolic pressure obtained in a resting, seated position following validated guidelines at time zero and 8 weeks 10. Food intake estimated using food diaries and analysed by using specific software at time zero and every 2 weeks until 8 weeks | — |
Countries
Italy
Contacts
Public ContactCristian;Marco Del Bo';Gobbetti
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Outcome results
None listed