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| Name | Class |
|---|---|
| Azienda Ospedaliero-Universitaria Careggi | OTHER |
| University of Florence | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whey protein-enriched nutritional supplement | Experimental | Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water |
|
| Control group | Active Comparator | Standard hospital diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whey protein-enriched nutritional supplement | Dietary Supplement | Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water |
| 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) |
| 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)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiara F Gheri, MD | Fondazione Don Carlo Gnocchi ETS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Don Carlo Gnocchi | Florence | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21167685 | Background | de Aguilar-Nascimento JE, Prado Silveira BR, Dock-Nascimento DB. Early enteral nutrition with whey protein or casein in elderly patients with acute ischemic stroke: a double-blind randomized trial. Nutrition. 2011 Apr;27(4):440-4. doi: 10.1016/j.nut.2010.02.013. Epub 2010 Dec 16. | |
| 22857881 | Background | Sugawara K, Takahashi H, Kashiwagura T, Yamada K, Yanagida S, Homma M, Dairiki K, Sasaki H, Kawagoshi A, Satake M, Shioya T. Effect of anti-inflammatory supplementation with whey peptide and exercise therapy in patients with COPD. Respir Med. 2012 Nov;106(11):1526-34. doi: 10.1016/j.rmed.2012.07.001. Epub 2012 Aug 3. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | Standard hospital diet |
|
| 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) |
| 25671415 | Background | Zhou LM, Xu JY, Rao CP, Han S, Wan Z, Qin LQ. Effect of whey supplementation on circulating C-reactive protein: a meta-analysis of randomized controlled trials. Nutrients. 2015 Feb 9;7(2):1131-43. doi: 10.3390/nu7021131. |
| 27150497 | Background | Fekete AA, Givens DI, Lovegrove JA. Can milk proteins be a useful tool in the management of cardiometabolic health? An updated review of human intervention trials. Proc Nutr Soc. 2016 Aug;75(3):328-41. doi: 10.1017/S0029665116000264. Epub 2016 May 6. |
| 20521985 | Background | Laviolette L, Lands LC, Dauletbaev N, Saey D, Milot J, Provencher S, LeBlanc P, Maltais F. Combined effect of dietary supplementation with pressurized whey and exercise training in chronic obstructive pulmonary disease: a randomized, controlled, double-blind pilot study. J Med Food. 2010 Jun;13(3):589-98. doi: 10.1089/jmf.2009.0142. |
| 23360676 | Background | Kerasioti E, Stagos D, Jamurtas A, Kiskini A, Koutedakis Y, Goutzourelas N, Pournaras S, Tsatsakis AM, Kouretas D. Anti-inflammatory effects of a special carbohydrate-whey protein cake after exhaustive cycling in humans. Food Chem Toxicol. 2013 Nov;61:42-6. doi: 10.1016/j.fct.2013.01.023. Epub 2013 Jan 27. |
| D008722 | Methods |