BENITIONSClinical Trial Intelligence

High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.

Phase 3 Completed NCT06381076

ConditionChronic Kidney Disease 5D
PhasePhase 3
SponsorUniversity of Florida
StatusCompleted
Enrollment39 participants
InterventionsLiposomal curcumin, Food colorant
Start dateFeb 3, 2025
Completion dateMay 13, 2025
Results postedJun 1, 2026

Summary

A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey.

High-sensitivity C-reactive Protein

12 weeks or 84 days · milligrams per liter (mg/L)

Intervention-1.39 ± 2.65 milligrams per liter (mg/L)
Control5.09 ± 2.43 milligrams per liter (mg/L)
p-value0.004

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