Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Liver Disease Clinical Trial

Official title:

Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02901119
• Other study ID #: CAAE-27430714.8.0000.5149
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: April 9, 2017
• Start date: July 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic liver disease, liver transplantation

Exclusion Criteria:

• Children, illiterate, elderly, renal failure

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases
• Nutrition Disorders

Intervention

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.

Locations

Country	Name	City	State
Brazil	UFMG Hospital	Belo horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Anthropometry	Two years
Primary	Nutritional status	Functionality - dynometry	Two years
Secondary	Heart rate variability	Heart rate variability	Two years
Secondary	Resting energy expenditure	Calorimetry	Two years