Nutritional Support for Cardiac Rehabilitation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04738994

Enrollment

Registered

2021-02-04

Start date

2018-05-25

Completion date

2019-12-31

Last updated

2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Rehabilitation

Keywords

whey protein, gut microbiota, interleukin 6, cardiac rehabilitation, nutritional supplement, inflammatory status

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.

Interventions

DIETARY_SUPPLEMENTwhey protein-enriched nutritional supplement

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

OTHERControl group

Standard hospital diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Gut Microbiota (GM)	Baseline (T0) and day 15 (T1)	Change in GM \[Time Frame: after 15 days (T1) from baseline (T0)\]
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 \[Time Frame: after 15 days (T1) from baseline (T0)\]
C-Reactive Protein (CRP)	Baseline (T0) and day 15 (T1)	Change in CRP \[Time Frame: after 15 days (T1) from baseline (T0)\]
Anti- inflammatory cytokine interleukin 10 (IL-10)	Baseline (T0) and day 15 (T1)	Change in IL-10 \[Time Frame: after 15 days (T1) from baseline (T0)\]

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026