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Nutritional Support for Cardiac Rehabilitation

NCT04738994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-02-04

No results posted yet for this study

Summary

In this randomized trial the primary outcome is to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 6 (IL-6).

Hypothesis: Secondary outcomes are to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 1β (IL-1 β), tumor necrosis factor and C Reactive Protein (CRP); may increase anti-inflammatory interleukin 10 (IL-10) plasma concentrations and may change Gut Microbiota (GM) composition.

Conditions

  • Cardiac Rehabilitation

Interventions

DIETARY_SUPPLEMENT

whey protein-enriched nutritional supplement

Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water

OTHER

Control group

Standard hospital diet

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    collaborator OTHER

  • University of Florence

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Chiara F Gheri, MD · Fondazione Don Carlo Gnocchi Onlus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Italy

Study Locations

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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 NCT04738994 on ClinicalTrials.gov