Nutritional Support for Cardiac Rehabilitation

Cardiac Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738994
• Other study ID #: wheyprotein1_FDG
• Status: Completed
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

Dietary Supplement:
• 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

Other:
• Control group
Standard hospital diet

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi	Firenze

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Azienda Ospedaliero-Universitaria Careggi, University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. Erratum in: Nutrition. 2011 Sep;27(9):982. — View Citation

Fekete ÁA, 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pro-inflammatory cytokine interleukin 1beta (IL-1ß)	Change in IL-1ß [Time Frame: after 15 days (T1) from baseline (T0)]	Baseline (T0) and day 15 (T1)
Secondary	Tumor Necrosis Factor (TNF)	Change in TNF [Time Frame: after 15 days (T1) from baseline (T0)]	Baseline (T0) and day 15 (T1)
Secondary	C-Reactive Protein (CRP)	Change in CRP [Time Frame: after 15 days (T1) from baseline (T0)]	Baseline (T0) and day 15 (T1)
Secondary	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)
Secondary	Gut Microbiota (GM)	Change in GM [Time Frame: after 15 days (T1) from baseline (T0)]	Baseline (T0) and day 15 (T1)