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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water
Standard hospital diet
Fondazione Don Carlo Gnocchi
Florence, Italy
Pro-inflammatory cytokine interleukin 6 (IL-6)
Change in IL-6 \[Time Frame: after 15 days (T1) from baseline (T0)\]
Time frame: Baseline (T0) and day 15 (T1)
Pro-inflammatory cytokine interleukin 1beta (IL-1β)
Change in IL-1β \[Time Frame: after 15 days (T1) from baseline (T0)\]
Time frame: Baseline (T0) and day 15 (T1)
Tumor Necrosis Factor (TNF)
Change in TNF \[Time Frame: after 15 days (T1) from baseline (T0)\]
Time frame: Baseline (T0) and day 15 (T1)
C-Reactive Protein (CRP)
Change in CRP \[Time Frame: after 15 days (T1) from baseline (T0)\]
Time frame: Baseline (T0) and day 15 (T1)
Anti- inflammatory cytokine interleukin 10 (IL-10)
Change in IL-10 \[Time Frame: after 15 days (T1) from baseline (T0)\]
Time frame: Baseline (T0) and day 15 (T1)
Gut Microbiota (GM)
Change in GM \[Time Frame: after 15 days (T1) from baseline (T0)\]
Time frame: Baseline (T0) and day 15 (T1)
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