Nutritional Support for Cardiac Rehabilitation

NCT04738994 | Completed

• 1 other identifier: wheyprotein1_FDG
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation

Keywords

whey protein; gut microbiota; interleukin 6; cardiac rehabilitation; nutritional supplement; inflammatory status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pro-inflammatory cytokine interleukin 1beta (IL-1β)

  Baseline (T0) and day 15 (T1)

• Tumor Necrosis Factor (TNF)

  Baseline (T0) and day 15 (T1)

• C-Reactive Protein (CRP)

  Baseline (T0) and day 15 (T1)

• Anti- inflammatory cytokine interleukin 10 (IL-10)

  Baseline (T0) and day 15 (T1)

• Gut Microbiota (GM)

  Baseline (T0) and day 15 (T1)

Study Arms (2)

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

Dietary Supplement: whey protein-enriched nutritional supplement

Control group

ACTIVE COMPARATOR

Standard hospital diet

Other: Control group

Interventions

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

whey protein-enriched nutritional supplement

Control group OTHER

Standard hospital diet

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission for cardiac rehabilitation
• Signed informed consent

You may not qualify if:

• Patient unable to eat orally
• Eating disorders
• Indication to Levodopa therapy
• Gastrointestinal malignant diseases
• Known kidney failure
• Known liver failure
• Previous antibiotic therapy
• Refusal

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Azienda Ospedaliero-Universitaria Careggi: collaborator
• University of Florence: collaborator

Study Sites (1)

Fondazione Don Carlo Gnocchi

Florence, 50143, Italy

Location

Related 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.

  PMID: 21167685 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.

  PMID: 22857881 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.

  PMID: 25671415 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.

  PMID: 27150497 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.

  PMID: 20521985 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.

  PMID: 23360676 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Chiara F Gheri, MD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 4, 2021
• Study Start: May 25, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)