Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure (PROT-HF)
Effect of Supplementation With Whey Protein in Preservation of Muscle Mass and Strength, Quality of Life of Patients With Heart Failure in Cardiac Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio de Janeiro, Brazil, 22240-006
- Elisa Maia dos Santos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: whey protein
The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks)
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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.
Other Names:
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PLACEBO_COMPARATOR: placebo group
The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks)
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Preservation of skeletal muscle mass
Time Frame: 12 weeks
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Assessment of body composition through bioelectrical impedance and anthropometry
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of life
Time Frame: 12 weeks
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Evaluation of health-related quality of life through the application of the Minnesota Living With Heart Failure Questionnaire validated for brazilian population
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12 weeks
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Muscle strength
Time Frame: 12 weeks
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Evaluation of manual gripping force through dynamometry
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12 weeks
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Change in peak oxygen uptake (VO2 peak)
Time Frame: 12 weeks
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Cardiopulmonary exercise test will be performed to measure VO2 peak and other parameters representative of cardiovascular reserve.
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12 weeks
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Microvascular reactivity
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
Investigators
- Study Director: Andrea Lorenzo, PhD, National Institute of Cardiology, Laranjeiras, Brazil
- Study Director: Annie SB Moreira, PhD, National Institute of Cardiology, Laranjeiras, Brazil
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Whey Protein NICBrazil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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