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

Not Applicable

Completed

• Conditions: Intestinal permeability (IP); Digestive System

• Registration Number: ISRCTN10214981
• Lead Sponsor: European Joint Programming Initiative A Healthy Diet for a Healthy Life” (JPI - HDHL)

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32102662 protocol (added 28/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33388204/ results (added 04/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34534897/ (added 21/09/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34727202/ (added 03/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35315592/ (added 23/03/2022) 2020 Interim results article in https://doi.org/10.3390/nu12082458 (added 06/06/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39182041/ (added 27/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-28
• Study Completion: 2019-12-31
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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