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Innovative Functional Food Based on Apulian Lens Culinaris for Contrasting Sarcopenia in Dialysis Patients

NCT04223206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-03

No results posted yet for this study

Summary

The objective of the pilot study is to validate the clinical use of a dietary supplement for contrasting sarcopenia in dialysis patients.

The study aims at evaluating the effects of a nutritional supplement, consisting of flour from Lens culinaris of Altamura IGP, pea proteins and vitamins (A, B12, D, E) by achieving the following objectives:

* Reduction of sarcopenia conditions, through improvement of nutritional and anthropometrical levels
* Decrease of the serum levels of microbiota-derived uremic toxins
* Reduction of intestinal permeability and inflammatory markers

Conditions

Interventions

DIETARY_SUPPLEMENT

NATURLENS

Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water

Sponsors & Collaborators

  • University of Bari Aldo Moro

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Principal Investigators

  • Loreto Gesualdo, MD Full Prof · Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-01-15
Completion
2021-03-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223206 on ClinicalTrials.gov