Chronic Kidney Disease 5DPhase 3NCT06381076
High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.
A Phase 3 study testing Liposomal curcumin and Food colorant in people with Chronic Kidney Disease 5D, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease 5D
- What is being tested?
- Liposomal curcumin and Food colorant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 13 May 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease 5D
- Being tested
- Liposomal curcumin, Food colorant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal curcuminDrug
Also called Manna Liposomal Curcumin
participants will consume the product ad libitum for the 24 treatments.
Food colorantDrug
Also called ChefMaster
participants will consume the product ad libitum for the 24 treatments as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Drug: Liposomal curcumin |
| Control | Placebo comparator | 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. Receives: Drug: Food colorant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks or 84 days
Secondary outcomes (5)
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
Measured: 12 weeks or 84 days
Fatty Acid Byproduct - 4-hydroxynon-enal
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks or 84 days
Klotho
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.
Measured: 12 weeks or 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start3 Feb 2025
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized comparator-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanette M Andrade, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381076
- Sponsor's protocol ID
- IRB202400087
- Status last verified
- Aug 2025
- First submitted
- 19 Apr 2024
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No