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Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis.


Description

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.This is a 12-week double-blind randomized controlled trial to evaluate the impact of liposomal curcumin in a high-protein product on inflammation markers for adults undergoing hemodialysis. CRP and oxidative stress will be assessed from monthly blood samples using Elisa kits. Quality of life will be measured using the standard 36-item kidney disease

Trial Eligibility

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.

Study Info

Organization

University of Florida


Primary Outcome

high-sensitivity C-reactive protein


Outcome Timeframe 12 weeks or 84 days

NCTID NCT06381076

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2025-02-03

Completion Date 2025-08

Enrollment Target 30

Interventions

DRUG Liposomal curcumin

DRUG Food colorant

Locations Recruiting

University of Florida

United States, Florida, Gainesville


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