High-protein supplement with liposomal curcumin for adults on hemodialysis
Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis.
This study is testing whether a high-protein supplement with a special ingredient called liposomal curcumin can reduce inflammation and improve quality of life for adults on hemodialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06381076 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a 12-week double-blind randomized controlled trial aimed at evaluating the effects of a high-protein oral supplement containing liposomal curcumin on inflammation markers and oxidative stress in adults undergoing hemodialysis. A total of 15 participants will be randomized into two groups, receiving either the supplement with or without liposomal curcumin. Blood samples will be collected at baseline, week 8, and week 12 to assess changes in inflammation and oxidative stress, alongside quality of life evaluations using a standardized instrument. The study will also include dietary recalls to monitor participants' nutritional intake during the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with stage 5 chronic kidney disease who have been receiving hemodialysis for at least three months.
Not a fit: Patients with chronic kidney disease stages 1-4 or those undergoing peritoneal dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve inflammation management and overall quality of life for patients undergoing hemodialysis.
How similar studies have performed: While the specific combination of high-protein supplements and liposomal curcumin is novel, similar studies have shown promise in managing inflammation in hemodialysis patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Jeanette M Andrade, PhD — University of Florida
- Study coordinator: Jeanette M Andrade, PhD
- Email: jandrade1@ufl.edu
- Phone: 3522943975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.