Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Not Applicable

• Conditions: Liver Disease; Nutrition Disorders
• Interventions: Dietary Supplement: Whey protein

• Registration Number: NCT02901119
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-02-04
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-15
• Last Update Submitted: 2017-04-09
• Last Update Posted: 2017-04-11
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Chronic liver disease, liver transplantation

Exclusion Criteria

• Children, illiterate, elderly, renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Casein	Whey protein	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.
Whey protein	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.

Primary Outcome Measures

Name	Time	Method
Nutritional status	Two years	Functionality - dynometry

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	Two years	Heart rate variability
Resting energy expenditure	Two years	Calorimetry

Trial Locations

Locations (1)

UFMG Hospital; 🇧🇷 Belo horizonte, Minas Gerais, Brazil