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

• Register: ISRCTN
• Last refreshed on: 20 June 2023
• Main ID: ISRCTN10214981
• Date of registration: 28/04/2017
• Prospective Registration: No
• Primary sponsor: European Joint Programming Initiative “A Healthy Diet for a Healthy Life” (JPI - HDHL)
• Public title: Effect of a polyphenol-rich diet on leaky gut in the elderly
• Scientific title: Gut and blood microbiomics for studying the effect of a polyphenol-rich dietary pattern on intestinal permeability in the elderly
• Date of first enrolment: 01/06/2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10214981
• Study type: Interventional
• Study design: Randomised controlled cross over study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Patrizia Riso

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 period where they follow their regular diet and then the other diet for eight weeks.

Polyphenol-rich (PR)-diet: Participants consume a diet developed to double the amount of polyphenols intake (as recorded in the population under study) providing three portion of polyphenol-rich food products daily (i.e about 750 mg of total polyphenols are added to the amount regularly introduced). The following polyphenol-rich products have been considered in the PR-diet: berries and derived products, blood oranges and derived products, pomegranate juice, renetta apple and purée, green tea and dark chocolate products.

The control diet (C-diet): Participants consume a comparable diet for eight weeks without thepolyphenol-rich products.

Before and after each study diet period (at baseline, 8, 16 and 24 weeks), participants provide blood, urine and stool samples.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Ministero delle Politiche Agricole Alimentari e Forestali, Biotechnology and Biological Sciences Research Council, PCIN-2015-238 Ministry of Economy, Industry and Competitiveness, Spanish government

Ethics review

Status:
Approval date:
Contact:

Ethics Committee of the University of Milan, 15/02/2016, ref: 6/16 CE_15.02.16_Verbale_All-7

Results

• Results available: Yes
• Date Completed: 31/12/2019