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Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02901119
Recruitment Status : Unknown
Verified September 2016 by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais.
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

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

Condition or disease Intervention/treatment Phase
Liver Disease Nutrition Disorders Dietary Supplement: Whey protein Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation
Study Start Date : July 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

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.
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.
Other Name: Casein

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.
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.
Other Name: Casein




Primary Outcome Measures :
  1. Nutritional status [ Time Frame: Two years ]
    Anthropometry

  2. Nutritional status [ Time Frame: Two years ]
    Functionality - dynometry


Secondary Outcome Measures :
  1. Heart rate variability [ Time Frame: Two years ]
    Heart rate variability

  2. Resting energy expenditure [ Time Frame: Two years ]
    Calorimetry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic liver disease, liver transplantation

Exclusion Criteria:

  • Children, illiterate, elderly, renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901119


Locations
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Brazil
UFMG Hospital Recruiting
Belo horizonte, Minas Gerais, Brazil, 30640100
Contact: Isabel TD Correia, PhD    +553191688239    isabel_correia@uol.com.br   
Sponsors and Collaborators
Federal University of Minas Gerais

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Responsible Party: Maria Isabel Toulson Davisson Correia, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02901119     History of Changes
Other Study ID Numbers: CAAE-27430714.8.0000.5149
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Diseases
Nutrition Disorders
Digestive System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action