Phase 3 N=39 Randomized Double-blind Treatment

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

Chronic Kidney Disease 5D

Bottom Line

View on ClinicalTrials.gov: NCT06381076 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2026

Primary outcome: Primary: High-sensitivity C-reactive Protein — 11.16; 11.84 milligrams per liter (mg/L) — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Liposomal curcumin (Drug); Food colorant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY High-sensitivity C-reactive Protein	11.16; 11.84	0.004 sig
SECONDARY Advanced Glycation End Products	—	—
SECONDARY Fatty Acid Byproduct - 4-hydroxynon-enal	—	—
SECONDARY Fatty Acid Byproduct - Malondialdehyde	1.99; 1.78	0.023 sig
SECONDARY Fatty Acid Byproduct - 8-F2 Isoprostanes	—	—
SECONDARY Klotho	—	—

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.

Eligibility Criteria

Inclusion Criteria

18 years old or older
diagnosed with stage 5 CKD.
receiving hemodialysis at least three months before the trial start date
All participants can provide signed informed consent, have no dietary restrictions, no food allergies, nor chewing/swallowing difficulties.

Exclusion Criteria

Adults with CKD stages 1-4.
Adults undergoing peritoneal dialysis.
Pregnant and/or lactating for the duration of the study as confirmed by the dialysis medical staff.
Use of other IP within 3 months of the initiation of the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06381076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.