Nutritional Support for Cardiac Rehabilitation

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Dietary Supplement: whey protein-enriched nutritional supplement
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whey protein-enriched nutritional supplement<br>Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water | Dietary Supplement: whey protein-enriched nutritional supplement<br>* Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water<br>|
| Active Comparator: Control group<br>Standard hospital diet | Other: Control group<br>* Standard hospital diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pro-inflammatory cytokine interleukin 6 (IL-6) | Change in IL-6 [Time Frame: after 15 days (T1) from baseline (T0)] | Baseline (T0) and day 15 (T1) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whey protein, gut microbiota, interleukin 6, cardiac rehabilitation, nutritional supplement, inflammatory status