Nutritional Support for Cardiac Rehabilitation

• Sponsor: Fondazione Don Carlo Gnocchi Onlus (Other)
• Overall Status: Completed
• CT.gov ID: NCT04738994
• Collaborator: Azienda Ospedaliero-Universitaria Careggi (Other), University of Florence (Other)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rehabilitation	Dietary Supplement: whey protein-enriched nutritional supplement; Other: Control group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program
• Actual Study Start Date: May 25, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
Active Comparator: Control group Standard hospital diet	Other: Control group; Standard hospital diet

Outcome Measures

Primary Outcome Measures

1. Pro-inflammatory cytokine interleukin 6 (IL-6) [Baseline (T0) and day 15 (T1)]

   Change in IL-6 [Time Frame: after 15 days (T1) from baseline (T0)]

Secondary Outcome Measures

1. Pro-inflammatory cytokine interleukin 1beta (IL-1β) [Baseline (T0) and day 15 (T1)]

   Change in IL-1β [Time Frame: after 15 days (T1) from baseline (T0)]

2. Tumor Necrosis Factor (TNF) [Baseline (T0) and day 15 (T1)]

   Change in TNF [Time Frame: after 15 days (T1) from baseline (T0)]

3. C-Reactive Protein (CRP) [Baseline (T0) and day 15 (T1)]

   Change in CRP [Time Frame: after 15 days (T1) from baseline (T0)]

4. Anti- inflammatory cytokine interleukin 10 (IL-10) [Baseline (T0) and day 15 (T1)]

   Change in IL-10 [Time Frame: after 15 days (T1) from baseline (T0)]

5. Gut Microbiota (GM) [Baseline (T0) and day 15 (T1)]

   Change in GM [Time Frame: after 15 days (T1) from baseline (T0)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Don Carlo Gnocchi	Firenze		Italy	50143

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Chiara F Gheri, MD, Fondazione Don Carlo Gnocchi Onlus

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Fondazione Don Carlo Gnocchi Onlus
• ClinicalTrials.gov Identifier: NCT04738994
• Other Study ID Numbers: wheyprotein1_FDG
• First Posted: Feb 4, 2021
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondazione Don Carlo Gnocchi Onlus: whey protein; gut microbiota; interleukin 6; cardiac rehabilitation; nutritional supplement; inflammatory status

Study Results

No Results Posted as of Feb 4, 2021