Heart FailurePROT-HFNCT03142399
Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure
A study testing whey protein in people with Heart Failure and Sarcopenia, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
The aim of this study is evaluate the effect of whey protein supplementation on muscle mass preservation, improvement of strength and quality of life, and inflammatory parameters in patients with heart failure NYHA I or II followed by a cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Sarcopenia, Muscle Loss
- What is being tested?
- whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2018to 30 Jun 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
- Clinical diagnosis of heart failure NYHA I or II after medical evaluation;
- Indication to participate in a cardiac rehabilitation program;
- Fully medicated for heart disease;
- Age greater than or equal to 50 years;
- Ejection fraction less than 50%.
Who cannot join
- Neoplasia at any site;
- Impaired renal function (<50ml / min / 1.73m2);
- Impaired hepatic function (TGP> 150U / l) or decompensated hepatic cirrhosis classified with Child-Pugh B or C;
- Presence of ressincronizer or other device;
- Atrial fibrilation;
- Allergy of milk protein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supplementation With Whey Protein in Preservation of Muscle Mass and Strength, Quality of Life of Patients With Heart Failure in Cardiac Rehabilitation
The aim of this study is evaluate the effect of whey protein supplementation on muscle mass preservation, improvement of strength and quality of life, and inflammatory parameters in patients with heart failure NYHA I or II followed by a cardiac rehabilitation program.
Read the detailed description
Heart failure is the final route of most heart diseases and is a worldwide problem due to its high prevalence, morbidity and mortality. In Brazil, it is an important cause of hospitalization and one of the most important health challenges, since its prevalence tends to increase with the aging of the population and the increase in the survival of patients who have suffered acute coronary events. This is an ongoing epidemic problem, resulting in a high socioeconomic cost, represented by the expense of medications, repeated hospitalizations, loss of productivity, early retirements, possible surgeries and, ultimately, heart transplantation. In this sense, it is of great importance to carry out studies that evaluate the possible benefits of new clinical and nutritional interventions for HF patients, favoring the development of treatment strategies for these individuals and also for public health.
Our hypothesis is based on the fact that whey protein supplementation associated with physical exercise in patients with heart failure could promote preservation of muscle mass, increase in muscle strength, and improve quality of life, Body composition and physical capacity. The volunteers will receive 30 grams per day of whey protein or maltodextrin in a double-blind, controlled clinical trial lasting 12 weeks. During this period they will perform supervised physical exercise 3 times a week in a cardiac rehabilitation program. They will also receive nutritional counseling.
- Conditions
- Heart Failure, Sarcopenia, Muscle Loss, Quality of Life
- Being tested
- whey protein
- Keywords
- heart failure, cardiac reabilitation, nutritional status, quality of life, milk protein
- Medical subject headings
- Heart Failure, Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinDietary supplement
Also called supplementation with milk protein
Supplementation with whey protein isolate or maltodextrin (30 grams per day) for 12 weeks associated with supervised exercise and nutritional counseling in patients with heart failure.
| Study group | Role | What they receive |
|---|---|---|
| whey protein | Experimental | The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks) Receives: Dietary Supplement: whey protein |
| placebo group | Placebo comparator | The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks) Receives: Dietary Supplement: whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preservation of skeletal muscle mass
Assessment of body composition through bioelectrical impedance and anthropometry
Measured: 12 weeks
Secondary outcomes (4)
Quality of life
Evaluation of health-related quality of life through the application of the Minnesota Living With Heart Failure Questionnaire validated for brazilian population
Measured: 12 weeks
Muscle strength
Evaluation of manual gripping force through dynamometry
Measured: 12 weeks
Change in peak oxygen uptake (VO2 peak)
Cardiopulmonary exercise test will be performed to measure VO2 peak and other parameters representative of cardiovascular reserve.
Measured: 12 weeks
Microvascular reactivity
A laser speckle contrast imaging system with a laser wavelength of 785 nm (PeriCam PSI system, Perimed, Järfälla, Sweden) coupled to iontophoresis of acetylcholine and sodium nitroprusside will measure non-invasively real time cutaneous microvascular flow changes in the forearm. For the post occlusive reactive hyperemia (PORH) test, arterial occlusion will be performed with suprasystolic pressure (50 mmHg above the systolic arterial pressure) using a sphygmomanometer applied to the arm of the subject over three minutes. Peak skin flow will be measured after pressure release.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start2 Jan 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elisa Maia dos Santos, National Institute of Cardiology, Laranjeiras, Brazil
- Investigators
- Andrea Lorenzo, PhD, Study director, National Institute of Cardiology, Laranjeiras, BrazilAnnie SB Moreira, PhD, Study director, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142399
- Sponsor's protocol ID
- Whey Protein NICBrazil
- Acronym
- PROT-HF
- Status last verified
- Dec 2017
- First submitted
- 3 May 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All volunteer information obtained during the collection, intervention and data analysis will not be available other researchers.
Publications
Dos Santos EM, de Moraes R, Tibirica EV, Huguenin GVB, Moreira ASB, De Lorenzo AR. Whey protein supplementation for the preservation of mass and muscular strength of patients with heart failure: study protocol for a randomized controlled trial. Trials. 2018 Aug 8;19(1):431. doi: 10.1186/s13063-018-2811-4.
PubMed 30089525
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With Whey Protein in Preservation of Muscle Mass and Strength, Quality of Life of Patients With Heart Failure in Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT03142399
- Acronym / sponsor ID
- PROT-HF / Whey Protein NICBrazil
- Conditions
- Heart Failure, Sarcopenia, Muscle Loss, Quality of Life
- Keywords
- heart failure, cardiac reabilitation, nutritional status, quality of life, milk protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 2 Jan 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 5 May 2017 (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.
The aim of this study is evaluate the effect of whey protein supplementation on muscle mass preservation, improvement of strength and quality of life, and inflammatory parameters in patients with heart failure NYHA I or II followed by a cardiac rehabilitation program.
Detailed description
Heart failure is the final route of most heart diseases and is a worldwide problem due to its high prevalence, morbidity and mortality. In Brazil, it is an important cause of hospitalization and one of the most important health challenges, since its prevalence tends to increase with the aging of the population and the increase in the survival of patients who have suffered acute coronary events. This is an ongoing epidemic problem, resulting in a high socioeconomic cost, represented by the expense of medications, repeated hospitalizations, loss of productivity, early retirements, possible surgeries and, ultimately, heart transplantation. In this sense, it is of great importance to carry out studies that evaluate the possible benefits of new clinical and nutritional interventions for HF patients, favoring the development of treatment strategies for these individuals and also for public health.
Our hypothesis is based on the fact that whey protein supplementation associated with physical exercise in patients with heart failure could promote preservation of muscle mass, increase in muscle strength, and improve quality of life, Body composition and physical capacity. The volunteers will receive 30 grams per day of whey protein or maltodextrin in a double-blind, controlled clinical trial lasting 12 weeks. During this period they will perform supervised physical exercise 3 times a week in a cardiac rehabilitation program. They will also receive nutritional counseling.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whey protein | Experimental | Dietary Supplement: whey proteinThe whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks) |
| placebo group | Placebo comparator | Dietary Supplement: whey proteinThe placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of heart failure NYHA I or II after medical evaluation;
- Indication to participate in a cardiac rehabilitation program;
- Fully medicated for heart disease;
- Age greater than or equal to 50 years;
- Ejection fraction less than 50%.
Key exclusion criteria (6 listed)
- Neoplasia at any site;
- Impaired renal function (<50ml / min / 1.73m2);
- Impaired hepatic function (TGP> 150U / l) or decompensated hepatic cirrhosis classified with Child-Pugh B or C;
- Presence of ressincronizer or other device;
- Atrial fibrilation;
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 proteinAlso: supplementation with milk proteinSupplementation with whey protein isolate or maltodextrin (30 grams per day) for 12 weeks associated with supervised exercise and nutritional counseling in patients with heart failure. | Dietary supplement | placebo group, whey protein |
Primary outcome
Preservation of skeletal muscle mass
Time frame: 12 weeks
Assessment of body composition through bioelectrical impedance and anthropometry
4 secondary outcomes
Quality of life
Time frame: 12 weeks
Muscle strength
Time frame: 12 weeks
Change in peak oxygen uptake (VO2 peak)
Time frame: 12 weeks
Microvascular reactivity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 30089525Dos Santos EM, de Moraes R, Tibirica EV, Huguenin GVB, Moreira ASB, De Lorenzo AR. Whey protein supplementation for the preservation of mass and muscular strength of patients with heart failure: study protocol for a randomized controlled trial. Trials. 2018 Aug 8;19(1):431. doi: 10.1186/s13063-018-2811-4.
- Individual participant dataSharing planned: No. All volunteer information obtained during the collection, intervention and data analysis will not be available other researchers.
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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.
Andrea Lorenzo, PhD study director
National Institute of Cardiology, Laranjeiras, Brazil
Annie SB Moreira, PhD study director
National Institute of Cardiology, Laranjeiras, Brazil
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 in people with Heart Failure and Sarcopenia, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Dec 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Preservation of skeletal muscle mass (time frame: 12 weeks). 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 NCT03142399, which also lists 1 linked publication.
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 12 Dec 2017.