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Effect of a polyphenol-rich diet on leaky gut in the elderly

Gut and blood microbiomics for studying the effect of a polyphenol-rich dietary pattern on intestinal permeability in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10214981
Enrollment
60
Registered
2017-04-28
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal permeability (IP) Digestive System Intestinal permeability (IP)

Interventions

Based on a computer randomization plan, subjects are randomized to receive the two study diets in a random order. Participants follow the diets for eight weeks, followed by an eight week washout perio

Sponsors

European Joint Programming Initiative “A Healthy Diet for a Healthy Life” (JPI - HDHL)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Intestinal permeability is evaluated by measuring Zonulin serum levels using an ELISA kit at baseline, 8, 16 and 24 weeks.

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 6, 2026