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OpenTrials
Completed

NCT Number: NCT04738994

Nutritional Support for Cardiac Rehabilitation

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.

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Key information

Conditions

Cardiac Rehabilitation

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Carlo Gnocchi

Florence, 50143, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

whey protein-enriched nutritional supplement

Dietary Supplement

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

Control Group

Other

Standard hospital diet

Primary outcomes

  1. 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)]

Secondary outcomes

  1. 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)]

  2. Tumor Necrosis Factor (TNF)

    Time frame: Baseline (T0) and day 15 (T1)

    Change in TNF [Time Frame: after 15 days (T1) from baseline (T0)]

  3. C-Reactive Protein (CRP)

    Time frame: Baseline (T0) and day 15 (T1)

    Change in CRP [Time Frame: after 15 days (T1) from baseline (T0)]

  4. 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)]

  5. Gut Microbiota (GM)

    Time frame: Baseline (T0) and day 15 (T1)

    Change in GM [Time Frame: after 15 days (T1) from baseline (T0)]

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi
  • University of Florence

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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