Nutritional Support for Cardiac Rehabilitation

Not Applicable

Completed

• Conditions: Cardiac Rehabilitation
• Interventions: Other: Control group; Dietary Supplement: whey protein-enriched nutritional supplement

• Registration Number: NCT04738994
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Standard hospital diet
whey protein-enriched nutritional 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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi; 🇮🇹 Firenze, Italy