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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03142399
Other study ID # Whey Protein NICBrazil
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 3, 2017
Last updated December 10, 2017
Start date January 2, 2018
Est. completion date June 30, 2019

Study information

Verified date December 2017
Source National Institute of Cardiology, Laranjeiras, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 4
Est. completion date June 30, 2019
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
whey 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.

Locations

Country Name City State
Brazil Elisa Maia dos Santos Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preservation of skeletal muscle mass Assessment of body composition through bioelectrical impedance and anthropometry 12 weeks
Secondary 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 12 weeks
Secondary Muscle strength Evaluation of manual gripping force through dynamometry 12 weeks
Secondary Change in peak oxygen uptake (VO2 peak) Cardiopulmonary exercise test will be performed to measure VO2 peak and other parameters representative of cardiovascular reserve. 12 weeks
Secondary 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. 12 weeks
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