Clinical trial NCT04738994: Nutritional Support for Cardiac Rehabilitation
Official title: Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: whey protein
gut microbiota
interleukin 6
cardiac rehabilitation
nutritional supplement
inflammatory status
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria Careggi
name: University of Florence
First posted: 2021-02-04
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pro-inflammatory cytokine interleukin 6 (IL-6)
timeFrame: Baseline (T0) and day 15 (T1)
Secondary outcomes:
measure: Pro-inflammatory cytokine interleukin 1beta (IL-1β)
timeFrame: Baseline (T0) and day 15 (T1)
measure: Tumor Necrosis Factor (TNF)
timeFrame: Baseline (T0) and day 15 (T1)
measure: C-Reactive Protein (CRP)
timeFrame: Baseline (T0) and day 15 (T1)
measure: Anti- inflammatory cytokine interleukin 10 (IL-10)
timeFrame: Baseline (T0) and day 15 (T1)
measure: Gut Microbiota (GM)
timeFrame: Baseline (T0) and day 15 (T1)
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Fondazione Don Carlo Gnocchi
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Chiara F Gheri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.