Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Overview

Malnutrition is prevalent among chronic liver disease patients. Inadequate ingestion and/or metabolic alterations modify the body composition and biological functions. The purpose of this study is to determine whether whey protein comsumption, due to amino acid profile, digestibility and bioactive compounds may be beneficial for patients waiting for liver transplantation

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2017

Detailed Description

A randomized, double-blind, intervention study in which patients are randomly assigned to receive packages of 20g of whey protein (WP) or casein (CA) to take twice a day (20g in the morning and 20g at night), as a supplement, during 15 days. They are monitored weekly by calls. Regular usual diet is maintained. Patients underwent muscle functionality assessment by handgrip dynamometry and 6-min. walking test and, the inflammatory response by plasmatic cytokines. All tests are performed at the beginning and the end of intervention.

Interventions

  • Dietary Supplement: Whey protein
    • Patients, maintaining their regular usual diet, are submitted to a protein supplementation, during 15 days. They recieve 20g packages of whey protein or casein, to take twice a day: 20g in the morning and 20g at night.

Arms, Groups and Cohorts

  • Experimental: Whey protein
    • Patients are instructed to consume 20g of whey protein in the morning and 20g at night, during 15 days, as a supplement. Their regular usual diet is maintained.
  • Active Comparator: Casein
    • Patients are instructed to consume 20g of casein in the morning and 20g at night, during 15 days, as a supplement. Their regular usual diet is maintained.

Clinical Trial Outcome Measures

Primary Measures

  • Nutritional status
    • Time Frame: Two years
    • Anthropometry
  • Nutritional status
    • Time Frame: Two years
    • Functionality – dynometry

Secondary Measures

  • Heart rate variability
    • Time Frame: Two years
    • Heart rate variability
  • Resting energy expenditure
    • Time Frame: Two years
    • Calorimetry

Participating in This Clinical Trial

Inclusion Criteria

  • Chronic liver disease, liver transplantation Exclusion Criteria:

  • Children, illiterate, elderly, renal failure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Isabel Toulson Davisson Correia, PhD – Federal University of Minas Gerais

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