Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Conditions
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Liver Disease, Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Whey protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic liver disease, liver transplantation Exclusion Criteria: Children, illiterate, elderly, renal failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein<br>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. | Dietary Supplement: Whey protein<br>* 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.<br>* Other names: Casein;|
| Active Comparator: Casein<br>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. | Dietary Supplement: Whey protein<br>* 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.<br>* Other names: Casein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Anthropometry | Two years | 
| Nutritional status | Functionality - dynometry | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Heart rate variability | Two years | 
| Resting energy expenditure | Calorimetry | Two years |