Effects of Whey Protein Consumption by Patients Waiting for Liver Transplantation

NCT02901119 | Unknown DMC

• 1 other identifier: CAAE-27430714.8.0000.5149
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Disease; Nutrition Disorders

Outcome Measures

Primary Outcomes (2)

• Nutritional status

  Anthropometry

  Two years

• Nutritional status

  Functionality - dynometry

  Two years

Secondary Outcomes (2)

• Heart rate variability

  Two years

• Resting energy expenditure

  Two years

Study Arms (2)

Whey protein

EXPERIMENTAL

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

Casein

ACTIVE COMPARATOR

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

Interventions

Whey protein 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.

Also known as: Casein

Casein; Whey protein

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic liver disease, liver transplantation

You may not qualify if:

• Children, illiterate, elderly, renal failure

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

UFMG Hospital

Belo Horizonte, Minas Gerais, 30640100, Brazil

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Nutrition Disorders

Interventions

Whey Proteins; Caseins

Condition Hierarchy (Ancestors)

Digestive System Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Phosphoproteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: September 15, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 11, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)