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Completed

NCT Number: NCT06381076

High-protein Oral Supplement With Liposomal Curcumin 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.

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Key information

Conditions

Chronic Kidney Disease 5D

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposomal curcumin

Drug

participants will consume the product ad libitum for the 24 treatments.

Other names: Manna Liposomal Curcumin

Food colorant

Drug

participants will consume the product ad libitum for the 24 treatments as a placebo.

Other names: ChefMaster

Primary outcomes

  1. High-sensitivity C-reactive Protein

    Time frame: 12 weeks or 84 days

    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.

Secondary outcomes

  1. Advanced Glycation End Products

    Time frame: 12 weeks or 84 days

    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

  2. Fatty Acid Byproduct - 4-hydroxynon-enal

    Time frame: 12 weeks or 84 days

    Between-group difference in change from baseline to endline in serum 4-hydroxynon-enal (micromoles per liter (μmol/L)), where higher values indicate more oxidative stress by the fatty acid production.

  3. Fatty Acid Byproduct - Malondialdehyde

    Time frame: 12 weeks or 84 days

    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.

  4. Fatty Acid Byproduct - 8-F2 Isoprostanes

    Time frame: 12 weeks or 84 days

    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.

  5. Klotho

    Time frame: 12 weeks or 84 days

    Between-group difference in change from baseline to endline in serum alpha klotho concentration, pg/mL, which is a marker of kidney function. A higher value indicates better kidney function.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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