Intestinal permeability (IP) Digestive System Intestinal permeability (IP)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 60 years old 2. Intestinal Permeability evaluated by Zonulin serum level 3. Adequate nutritional status evaluated with Mini Nutritional Assessment (MNA) score =24 4. Good cognitive status tested with Mini Mental State Evaluation (MMSE) score =24 5. Self-sufficiency assessed with validated tests (e.g. Barthel index - activities of daily living, Tinetti balance assessment)
Exclusion criteria
Exclusion criteria: 1. Celiac disease 2. Severe liver disease with cirrhosis 3. Severe renal insufficiency (dialysis) 4. Presence of Chronic Obstructive Pulmonary severe COPD (oxygen therapy for many hours a day) or severe heart failure, i.e. class III or IV NYHA - New York Heart Association 5. Antibiotic treatment 6. Malignant tumor that required treatment in the previous 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal permeability is evaluated by measuring Zonulin serum levels using an ELISA kit at baseline, 8, 16 and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fecal microbiota composition evaluated by 16S rRNA gene profiling with MiSeq-Illumina platform at baseline, 8, 16 and 24 weeks 2. Short chain fatty acids and polyphenol-derived metabolites measured with LC-MS system at baseline, 8, 16 and 24 weeks 3. Diet-induced changes in microbiota metabolism performed by NMR at baseline, 8, 16 and 24 weeks 4. LC-MS analysis are used for faecal water at baseline, 8, 16 and 24 weeks 5. Total blood bacterial load are assessed through a quantitative real-time PCR; taxomic profile investigated by 16S rRNA gene profiling with MiSeq-Illumina platform at baseline, 8, 16 and 24 weeks 6. Inflammatory markers, oxidative stress and related markers e.g. vascular cell adhesion molecule (VCAM)-1 and intracellular adhesion molecule (ICAM)-1 performed through ELISA kit at baseline, 8, 16 and 24 weeks 7. DNA damage assessed through Comet Assay at baseline, 8, 16 and 24 weeks 8. Endotoxin by Limulus Amebocyte Lysate (LAL) assay assessed to evaluate the inflammatory process and oxidative stress modulation at baseline, 8, 16 and 24 weeks 9. Metabolomic analysis will be performed on HPLC-ESI-Q-ToF-MS and NMR to understand the interaction of the polyphenol rich diet with the secondary metabolites of microbiota at baseline, 8, 16 and 24 weeks | — |
Countries
Italy