Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

NCT ID: NCT02901119

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Liver Disease Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Whey protein

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type ACTIVE_COMPARATOR

Whey protein

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Casein

Eligibility Criteria

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Inclusion Criteria

* Chronic liver disease, liver transplantation

Exclusion Criteria

* Children, illiterate, elderly, renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Toulson Davisson Correia

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UFMG Hospital

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Isabel TD Correia, PhD

Role: primary

+553191688239

Other Identifiers

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CAAE-27430714.8.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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