NCT03142399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

May 3, 2017

Last Update Submit

December 10, 2017

Conditions

Heart FailureSarcopeniaMuscle LossQuality of Life

Keywords

heart failurecardiac reabilitationnutritional statusquality of lifemilk protein

Outcome Measures

Primary Outcomes (1)

  • Preservation of skeletal muscle mass

    Assessment of body composition through bioelectrical impedance and anthropometry

    12 weeks

Secondary Outcomes (4)

  • Quality of life

    12 weeks

  • Muscle strength

    12 weeks

  • Change in peak oxygen uptake (VO2 peak)

    12 weeks

  • Microvascular reactivity

    12 weeks

Study Arms (2)

whey protein

EXPERIMENTAL

The whey protein group will receive whey protein supplementation 30g/day of whey protein during three months (12 weeks)

Dietary Supplement: whey protein

placebo group

PLACEBO COMPARATOR

The placebo group (maltodextrin) will receive 30g/day of maltodextrin during three months (12 weeks)

Dietary Supplement: whey protein

Interventions

whey proteinDIETARY_SUPPLEMENT

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.

Also known as: supplementation with milk protein
placebo groupwhey protein

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elisa Maia dos Santos

Rio de Janeiro, 22240-006, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 30089525DERIVED

MeSH Terms

Conditions

Heart FailureSarcopeniaMuscular Atrophy

Interventions

Whey ProteinsDietary SupplementsMilk Proteins

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Andrea Lorenzo, PhD

    National Institute of Cardiology, Laranjeiras, Brazil

    STUDY DIRECTOR

  • Annie SB Moreira, PhD

    National Institute of Cardiology, Laranjeiras, Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master on Cardiovascular Sciences

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

January 2, 2018

Primary Completion

December 30, 2018

Study Completion

June 30, 2019

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

All volunteer information obtained during the collection, intervention and data analysis will not be available other researchers.

Locations

BR(1)