NCT04738994

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Rehabilitation

Interventions

Type	Name	Description
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
OTHER	Control group	Standard hospital diet

Timeline

• Start date: 2018-05-25
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2021-02-04
• Last updated: 2021-02-04

Locations

1 site across 1 country: Italy