NCT05227755

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-08-05
• Primary completion: 2023-08-31
• Completion: 2023-11-21
• First posted: 2022-02-07
• Last updated: 2024-06-10

Locations

1 site across 1 country: United States