Nutritional Support for Cardiac Rehabilitation

February 3, 2021 updated by: Fondazione Don Carlo Gnocchi Onlus

Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Firenze, Italy, 50143
        • Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission for cardiac rehabilitation
  • Signed informed consent

Exclusion Criteria:

  • Patient unable to eat orally
  • Eating disorders
  • Indication to Levodopa therapy
  • Gastrointestinal malignant diseases
  • Known kidney failure
  • Known liver failure
  • Previous antibiotic therapy
  • Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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
ACTIVE_COMPARATOR: Control group
Standard hospital diet
Other: Control group
Standard hospital diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro-inflammatory cytokine interleukin 6 (IL-6)
Time Frame: Baseline (T0) and day 15 (T1)
Change in IL-6 [Time Frame: after 15 days (T1) from baseline (T0)]
Baseline (T0) and day 15 (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro-inflammatory cytokine interleukin 1beta (IL-1β)
Time Frame: Baseline (T0) and day 15 (T1)
Change in IL-1β [Time Frame: after 15 days (T1) from baseline (T0)]
Baseline (T0) and day 15 (T1)
Tumor Necrosis Factor (TNF)
Time Frame: Baseline (T0) and day 15 (T1)
Change in TNF [Time Frame: after 15 days (T1) from baseline (T0)]
Baseline (T0) and day 15 (T1)
C-Reactive Protein (CRP)
Time Frame: Baseline (T0) and day 15 (T1)
Change in CRP [Time Frame: after 15 days (T1) from baseline (T0)]
Baseline (T0) and day 15 (T1)
Anti- inflammatory cytokine interleukin 10 (IL-10)
Time Frame: Baseline (T0) and day 15 (T1)
Change in IL-10 [Time Frame: after 15 days (T1) from baseline (T0)]
Baseline (T0) and day 15 (T1)
Gut Microbiota (GM)
Time Frame: Baseline (T0) and day 15 (T1)
Change in GM [Time Frame: after 15 days (T1) from baseline (T0)]
Baseline (T0) and day 15 (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

University of Florence
Azienda Ospedaliero-Universitaria Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (ACTUAL)

February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • wheyprotein1_FDG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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