Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure (PROT-HF)

• ClinicalTrials.gov Identifier: NCT03142399
• Recruitment Status: Unknown
• First Posted: May 5, 2017
• Last Update Posted: December 12, 2017
• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil
• Information provided by (Responsible Party): Elisa Maia dos Santos, National Institute of Cardiology, Laranjeiras, Brazil

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Sarcopenia; Muscle Loss; Quality of Life	Dietary Supplement: whey protein	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Estimated Study Start Date: January 2, 2018
• Estimated Primary Completion Date: December 30, 2018
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: whey protein; The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks)	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.; Other Name: supplementation with milk protein
Placebo Comparator: placebo group; The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks)	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.; Other Name: supplementation with milk protein

Outcome Measures

Primary Outcome Measures :

1. Preservation of skeletal muscle mass [ Time Frame: 12 weeks ]
   Assessment of body composition through bioelectrical impedance and anthropometry

Secondary Outcome Measures :

1. Quality of life [ Time Frame: 12 weeks ]
   Evaluation of health-related quality of life through the application of the Minnesota Living With Heart Failure Questionnaire validated for brazilian population
2. Muscle strength [ Time Frame: 12 weeks ]
   Evaluation of manual gripping force through dynamometry
3. Change in peak oxygen uptake (VO2 peak) [ Time Frame: 12 weeks ]
   Cardiopulmonary exercise test will be performed to measure VO2 peak and other parameters representative of cardiovascular reserve.
4. Microvascular reactivity [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Elisa Maia dos Santos

Rio de Janeiro, Brazil, 22240-006

Sponsors and Collaborators

National Institute of Cardiology, Laranjeiras, Brazil

Investigators

• Study Director: Andrea Lorenzo, PhD; National Institute of Cardiology, Laranjeiras, Brazil
• Study Director: Annie SB Moreira, PhD; National Institute of Cardiology, Laranjeiras, Brazil

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Elisa Maia dos Santos, Master on Cardiovascular Sciences, National Institute of Cardiology, Laranjeiras, Brazil
• ClinicalTrials.gov Identifier: NCT03142399
• Other Study ID Numbers: Whey Protein NICBrazil
• First Posted: May 5, 2017
• Last Update Posted: December 12, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: All volunteer information obtained during the collection, intervention and data analysis will not be available other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elisa Maia dos Santos, National Institute of Cardiology, Laranjeiras, Brazil:

heart failure; cardiac reabilitation; nutritional status; quality of life; milk protein

Additional relevant MeSH terms:

Sarcopenia; Heart Failure; Heart Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical