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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease 5D
• Intervention / Treatment: Drug: Liposomal curcumin; Drug: Food colorant

Detailed Description

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 quality of life instrument. There will be a 2-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. Eligible participants will sign the consent form to participate in the study. Once the expected number of participants has been reached, they will be randomized 1:1 using block randomization. Randomization will be done using a computer-generated program.

The intervention will take place over an 8-week period. Participants will have their blood drawn at the beginning of the study by the dialysis practitioner and start receiving the product on their next scheduled dialysis appointment. Participants will be receiving the product three times a week in accordance with their dialysis schedule (M-W-F or T-Th-S), for a total of 24 treatments. Blood will be collected at baseline, at the end of the study and a month after to assess any carryover effects. Additionally, participants will complete 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day), a spice-consumption survey, and a quality-of-life assessment at the beginning and end of the study.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will consume 38 g of high protein product with 7 mls of curcumin at the end of each dialysis session, 3 days a week for 8 weeks for a total of 24 treatments.	Drug: Liposomal curcumin; participants will consume the product ad libitum for the 24 treatments.; Other Names: Manna Liposomal Curcumin
Placebo Comparator: Control; Participants will consume 38 g of high protein product that contains an orange food colorant at the end of each dialysis session, 3 days a week for 8 weeks for a total of 24 treatments.	Drug: Food colorant; participants will consume the product ad libitum for the 24 treatments as a placebo.; Other Names: ChefMaster

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-sensitivity C-reactive Protein	Between-group difference in change from baseline to endline in serum high-sensitivity C-reactive protein (hs-CRP) concentration (mg/L), where higher values indicate greater systemic inflammation. Typical ranges for high-sensitivity C-reactive protein for individuals on hemodialysis is from 5 - 50 mg/L, in which a higher value indicates more inflammation.	12 weeks or 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Klotho	baseline to end line in the concentration of klotho between the control and intervention group.	12 weeks or 84 days
Advanced Glycation End Products	Between-group difference in change from baseline to endline in serum advanced glycation end product concentrations (micrograms per milliter (ug/mL)), where higher values indicate greater oxidative stress	12 weeks or 84 days
Fatty Acid Byproduct - 4-hydroxynon-enal	baseline to end line in the concentration of fatty acid byproduct - 4-hydroxynon-enal between the control and intervention group.	12 weeks or 84 days
Fatty Acid Byproduct - Malondialdehyde	Between-group difference in change from baseline to endline in plasma malondialdehyde (MDA) concentration (micromol per liter (µmol/L)), a marker of lipid peroxidation, where higher values indicate greater oxidative stress.	12 weeks or 84 days
Fatty Acid Byproduct - 8-F2 Isoprostanes	Between-group difference in change from baseline to endline in serum 8-F2 isoprostane concentration (picograms per milliliter (pg/mL)), where higher values indicate more oxidative stress by the fatty acid production.	12 weeks or 84 days

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Jeanette M Andrade, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Actual): May 13, 2025
• Study Completion (Actual): May 13, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Curcumin
• Other Study ID Numbers: IRB202400087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No