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Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Unknown status
CT.gov ID
NCT02901119
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
53
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Whey protein
 N/A

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
Anticipated 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 :
Jul 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • Casein

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nutritional status [Two years]

      Anthropometry

    2. Nutritional status [Two years]

      Functionality - dynometry

    Secondary Outcome Measures

    1. Heart rate variability [Two years]

      Heart rate variability

    2. Resting energy expenditure [Two years]

      Calorimetry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic liver disease, liver transplantation
    Exclusion Criteria:
    • Children, illiterate, elderly, renal failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UFMG Hospital Belo horizonte Minas Gerais Brazil 30640100

    Sponsors and Collaborators

    • Federal University of Minas Gerais

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Isabel Toulson Davisson Correia, PhD, Federal University of Minas Gerais
    ClinicalTrials.gov Identifier:
    NCT02901119
    Other Study ID Numbers:
    • CAAE-27430714.8.0000.5149
    First Posted:
    Sep 15, 2016
    Last Update Posted:
    Apr 11, 2017
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Nutrition Disorders

    Study Results

    No Results Posted as of Apr 11, 2017