High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

University of Florida15 enrolled

Overview

The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Renal Failure Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old or older * diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial * 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial * All participants have the ability to provide signed informed consent * have not been newly diagnosed * not present with symptomatic infection of COVID-19 * have no dietary restriction * no food allergies * no chewing/swallowing difficulties Exclusion Criteria: * CKD patient stages 1-4. * CKD patient undergoing peritoneal hemodialysis. * In isolation due to COVID-19 or other infectious disease * Adult pregnant and/or lactating for the duration of the study. * Any other renal disease autoimmune or otherwise. * Use of other IP within 3 months prior of the eligibility screening.

Outcomes

Primary Outcomes

C-reactive protein

Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.