Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Pro-inflammatory cytokine interleukin 6 (IL-6)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: whey protein-enriched nutritional supplement (Dietary Supplement)
Control group
Standard hospital diet
Intervention: Control group (Other)
Outcomes
Primary Outcomes
Pro-inflammatory cytokine interleukin 6 (IL-6)
Time Frame: Baseline (T0) and day 15 (T1)
Change in IL-6 \[Time Frame: after 15 days (T1) from baseline (T0)\]
Secondary Outcomes
- Anti- inflammatory cytokine interleukin 10 (IL-10)(Baseline (T0) and day 15 (T1))
- Gut Microbiota (GM)(Baseline (T0) and day 15 (T1))
- C-Reactive Protein (CRP)(Baseline (T0) and day 15 (T1))
- Pro-inflammatory cytokine interleukin 1beta (IL-1β)(Baseline (T0) and day 15 (T1))
- Tumor Necrosis Factor (TNF)(Baseline (T0) and day 15 (T1))