Cardiac RehabilitationNCT04738994

Nutritional Support for Cardiac Rehabilitation

A study testing whey protein-enriched nutritional supplement in people with Cardiac Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Cardiac Rehabilitation
What is being tested?: whey protein-enriched nutritional supplement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteItaly
Study dates: 25 May 2018to 31 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Admission for cardiac rehabilitation
Signed informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione Don Carlo Gnocchi
Florence, 50143

Other trials in Italy

About this study

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

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
Being tested: whey protein-enriched nutritional supplement, Control group
Keywords: whey protein, gut microbiota, interleukin 6, cardiac rehabilitation, nutritional supplement, inflammatory status

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

whey protein-enriched nutritional supplementDietary supplement
Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water
Control groupOther
Standard hospital diet

Study groups in NCT04738994
Study group	Role	What they receive
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 Receives: Dietary Supplement: whey protein-enriched nutritional supplement
Control group	Active comparator	Standard hospital diet Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Pro-inflammatory cytokine interleukin 6 (IL-6)
Change in IL-6 [Time Frame: after 15 days (T1) from baseline (T0)]
Measured: Baseline (T0) and day 15 (T1)

Secondary outcomes (5)

Pro-inflammatory cytokine interleukin 1beta (IL-1β)
Change in IL-1β [Time Frame: after 15 days (T1) from baseline (T0)]
Measured: Baseline (T0) and day 15 (T1)
Tumor Necrosis Factor (TNF)
Change in TNF [Time Frame: after 15 days (T1) from baseline (T0)]
Measured: Baseline (T0) and day 15 (T1)
C-Reactive Protein (CRP)
Change in CRP [Time Frame: after 15 days (T1) from baseline (T0)]
Measured: 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)]
Measured: Baseline (T0) and day 15 (T1)
Gut Microbiota (GM)
Change in GM [Time Frame: after 15 days (T1) from baseline (T0)]
Measured: Baseline (T0) and day 15 (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201831 Dec 2019

First posted4 Feb 2021
Study start25 May 2018
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04738994
Sponsor's protocol ID: wheyprotein1_FDG
Status last verified: Feb 2021
First submitted: 2 Feb 2021
Last updated: 4 Feb 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 21167685
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.
PubMed 22857881
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.
PubMed 25671415
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.
PubMed 27150497
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.
PubMed 20521985
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.
PubMed 23360676

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
Not yet recruiting
VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
Heart Diseases
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)

All Cardiac Rehabilitation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program
ClinicalTrials.gov ID: NCT04738994
Acronym / sponsor ID: wheyprotein1_FDG
Conditions: Cardiac Rehabilitation
Keywords: whey protein, gut microbiota, interleukin 6, cardiac rehabilitation, nutritional supplement, inflammatory status
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
Collaborators: Azienda Ospedaliero-Universitaria Careggi, University of Florence
Study start: 25 May 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 4 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
whey protein-enriched nutritional supplement	Experimental	Dietary Supplement: whey protein-enriched nutritional supplementStandard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water
Control group	Active comparator	Other: Control groupStandard hospital diet

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Admission for cardiac rehabilitation
Signed informed consent

Key exclusion criteria (8 listed)

Patient unable to eat orally
Eating disorders
Indication to Levodopa therapy
Gastrointestinal malignant diseases
Known kidney failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
whey protein-enriched nutritional supplementStandard 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 groupStandard hospital diet	Other	Control group

Primary outcome

Pro-inflammatory cytokine interleukin 6 (IL-6)
Time frame: Baseline (T0) and day 15 (T1)
Change in IL-6 [Time Frame: after 15 days (T1) from baseline (T0)]

5 secondary outcomes

Pro-inflammatory cytokine interleukin 1beta (IL-1β)
Time frame: Baseline (T0) and day 15 (T1)
Tumor Necrosis Factor (TNF)
Time frame: Baseline (T0) and day 15 (T1)
C-Reactive Protein (CRP)
Time frame: Baseline (T0) and day 15 (T1)
Anti- inflammatory cytokine interleukin 10 (IL-10)
Time frame: Baseline (T0) and day 15 (T1)
Gut Microbiota (GM)
Time frame: Baseline (T0) and day 15 (T1)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Background: PubMed 21167685de 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.
Background: PubMed 22857881Sugawara 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.
Background: PubMed 25671415Zhou 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.
Background: PubMed 27150497Fekete 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.
Background: PubMed 20521985Laviolette 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.
Background: PubMed 23360676Kerasioti 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.
Individual participant dataSharing planned: No

Related trials for Cardiac Rehabilitation

Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
Not yet recruiting
VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
Heart Diseases
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chiara F Gheri, MD principal investigator

Fondazione Don Carlo Gnocchi ETS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing whey protein-enriched nutritional supplement in people with Cardiac Rehabilitation, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pro-inflammatory cytokine interleukin 6 (IL-6) (time frame: Baseline (T0) and day 15 (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04738994, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.