Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Primary Purpose
Liver Disease, Nutrition Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Whey protein
Sponsored by
About this trial
This is an interventional supportive care trial for Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Chronic liver disease, liver transplantation
Exclusion Criteria:
- Children, illiterate, elderly, renal failure
Sites / Locations
- UFMG HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whey protein
Casein
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Nutritional status
Anthropometry
Nutritional status
Functionality - dynometry
Secondary Outcome Measures
Heart rate variability
Heart rate variability
Resting energy expenditure
Calorimetry
Full Information
NCT ID
NCT02901119
First Posted
February 4, 2016
Last Updated
April 9, 2017
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT02901119
Brief Title
Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Official Title
Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease, Nutrition Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whey protein
Arm Type
Experimental
Arm Description
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.
Arm Title
Casein
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Whey protein
Other Intervention Name(s)
Casein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional status
Description
Anthropometry
Time Frame
Two years
Title
Nutritional status
Description
Functionality - dynometry
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
Heart rate variability
Time Frame
Two years
Title
Resting energy expenditure
Description
Calorimetry
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic liver disease, liver transplantation
Exclusion Criteria:
Children, illiterate, elderly, renal failure
Facility Information:
Facility Name
UFMG Hospital
City
Belo horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30640100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel TD Correia, PhD
Phone
+553191688239
Email
isabel_correia@uol.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
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