- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901119
Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
April 9, 2017 updated by: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Belo horizonte, Minas Gerais, Brazil, 30640100
- Recruiting
- UFMG Hospital
-
Contact:
- Isabel TD Correia, PhD
- Phone Number: +553191688239
- Email: isabel_correia@uol.com.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic liver disease, liver transplantation
Exclusion Criteria:
- Children, illiterate, elderly, renal failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Active Comparator: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional status
Time Frame: Two years
|
Anthropometry
|
Two years
|
Nutritional status
Time Frame: Two years
|
Functionality - dynometry
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: Two years
|
Heart rate variability
|
Two years
|
Resting energy expenditure
Time Frame: Two years
|
Calorimetry
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
September 9, 2016
First Posted (Estimate)
September 15, 2016
Study Record Updates
Last Update Posted (Actual)
April 11, 2017
Last Update Submitted That Met QC Criteria
April 9, 2017
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE-27430714.8.0000.5149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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