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

NCT05227755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-10

No results posted yet for this study

Summary

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.

Conditions

  • Renal Failure
  • Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

DIETARY_SUPPLEMENT

Soy protein isolate

Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

DIETARY_SUPPLEMENT

Whey protein isolate

Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2023-08-31
Completion
2023-11-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227755 on ClinicalTrials.gov