Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Nutritional status
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic liver disease, liver transplantation
Exclusion Criteria
- •Children, illiterate, elderly, renal failure
Arms & Interventions
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.
Intervention: Whey protein (Dietary Supplement)
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.
Intervention: Whey protein (Dietary Supplement)
Outcomes
Primary Outcomes
Nutritional status
Time Frame: Two years
Anthropometry
Secondary Outcomes
- Heart rate variability(Two years)
- Resting energy expenditure(Two years)
Investigators
Maria Isabel Toulson Davisson Correia
PhD
Federal University of Minas Gerais