Nutritional Support for Cardiac Rehabilitation

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Cardiac Rehabilitation

Treatments: Dietary Supplement: whey protein-enriched nutritional supplement; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04738994

wheyprotein1_FDG

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

whey protein-enriched nutritional supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: whey protein-enriched nutritional supplement

Control group

Active Comparator group

Description:

Standard hospital diet

Treatment:

Other: Control group