Liposomal Curcumin for Kidney Disease

Overseen By Sofia Acevedo, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Florida

Disqualifiers: CKD stages 1-4, Peritoneal dialysis, Pregnant, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 25

Duration: 8 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Liposomal Curcumin for kidney disease?

Research shows that curcumin, a key ingredient in Liposomal Curcumin, can help reduce inflammation and improve kidney health in patients with chronic kidney disease. Studies have found that curcumin can lower inflammation markers and improve kidney function in both animal models and small human trials. ^{1 2 3 4 5}

How is Liposomal Curcumin different from other treatments for kidney disease?

Liposomal Curcumin is unique because it uses a liposomal delivery system to enhance the bioavailability of curcumin, a natural compound with anti-inflammatory and antioxidant properties, which may help protect the kidneys and reduce inflammation more effectively than standard formulations. ^{2 4 6 7 8}

What is the purpose of this trial?

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.

Research Team

Jeanette M Andrade, PhD

Principal Investigator

University of Florida

Eligibility Criteria

Adults over 18 with stage 5 chronic kidney disease (CKD) who have been on hemodialysis for at least three months can join. They must be able to sign consent, have no dietary restrictions, food allergies, or problems with chewing/swallowing.

Inclusion Criteria

I can sign a consent form, have no food allergies, dietary restrictions, or problems with eating.

I have been diagnosed with stage 5 chronic kidney disease.

I have been on hemodialysis for at least three months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive 38 g of high protein product with or without 7 mls of liposomal curcumin at the end of each dialysis session, 3 days a week for 8 weeks

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples collected to assess carryover effects

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Liposomal Curcumin

Trial Overview The trial is testing if a high-protein oral supplement with liposomal curcumin helps reduce inflammation and oxidative stress in adults undergoing hemodialysis. It's a 12-week study where participants are randomly assigned to receive the supplement with or without curcumin.

Participant Groups

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

Curcumin intake significantly reduced total cholesterol levels and tumor necrosis factor alpha (TNF-α) in patients with chronic kidney disease, indicating its potential anti-inflammatory and lipid-lowering effects.

The meta-analysis included nine studies, showing that while curcumin had a positive impact on total cholesterol and TNF-α, it did not significantly affect triglycerides, LDL, HDL, or C-reactive protein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of curcumin-containing supplementations on inflammatory markers and lipid profiles in patients with chronic kidney diseases: a systematic review and meta-analysis of randomized controlled trials. Futuhi, F., Naghibzadeh Tahami, A., Azmandian, J., et al.[2022]

In a study involving 28 hemodialysis patients, 12 weeks of curcumin supplementation significantly reduced plasma levels of the inflammatory marker TNF-α, indicating its potential anti-inflammatory effects in chronic kidney disease.

The study supports the hypothesis that curcumin can help mitigate inflammation in patients undergoing hemodialysis, which may improve their overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin supplementation improves oxidative stress and inflammation biomarkers in patients undergoing hemodialysis: a secondary analysis of a randomized controlled trial. Alvarenga, L., Cardozo, LFMF., Da Cruz, BO., et al.[2022]

Curcumin, a safe and inexpensive compound from turmeric, shows promise in treating renal fibrosis by reducing inflammation and extracellular matrix deposition in animal models.

The antifibrotic effects of curcumin are linked to its ability to lower inflammatory factors and activate anti-inflammatory pathways, targeting key signaling pathways involved in kidney health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances of Curcumin in the Prevention and Treatment of Renal Fibrosis. Sun, X., Liu, Y., Li, C., et al.[2022]

In a randomized, double-blind, placebo-controlled trial involving 533 adults with chronic kidney disease (CKD), micro-particle curcumin (90 mg/day) did not significantly reduce albuminuria or slow the decline in kidney function over a 6-month period.

The study found no meaningful differences in changes in albuminuria or estimated glomerular filtration rate (eGFR) between the curcumin and placebo groups, suggesting that this formulation of curcumin may not be effective for managing CKD progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial. Weir, MA., Walsh, M., Cuerden, MS., et al.[2023]

In a randomized, placebo-controlled study of 24 patients with relapsing or refractory lupus nephritis, oral curcumin supplementation significantly reduced proteinuria, hematuria, and systolic blood pressure over a 3-month period.

No adverse effects were reported from curcumin supplementation, suggesting it is a safe adjuvant therapy for patients with lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral supplementation of turmeric decreases proteinuria, hematuria, and systolic blood pressure in patients suffering from relapsing or refractory lupus nephritis: a randomized and placebo-controlled study. Khajehdehi, P., Zanjaninejad, B., Aflaki, E., et al.[2022]

Curcumin demonstrated therapeutic effects in two mouse models of kidney disease, significantly reducing symptoms like proteinuria and blood urea nitrogen, indicating its potential to improve both acute and chronic kidney injury.

The study found that curcumin treatment lowered the activation of key inflammatory pathways (NFkB, MAPK, AKT, and pBAD), suggesting a mechanism by which it exerts its immunomodulatory and anti-inflammatory effects in kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin Attenuates Both Acute and Chronic Immune Nephritis. Wu, T., Marakkath, B., Ye, Y., et al.[2023]

Curcumin, a natural compound from the Curcuma longa plant, has demonstrated significant renoprotective effects in various experimental models of kidney injury, including diabetic nephropathy and chronic renal failure.

The protective effects of curcumin are linked to its ability to induce antioxidant responses, preserve mitochondrial function, and reduce inflammation, making it a promising therapeutic agent for preventing renal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renoprotective effect of the antioxidant curcumin: Recent findings. Trujillo, J., Chirino, YI., Molina-Jijón, E., et al.[2022]

In a pilot study involving 24 chronic kidney disease (CKD) patients, curcumin supplementation for six months significantly reduced pro-inflammatory markers and improved gut microbiota composition, suggesting potential benefits for CKD management.

The study reported no adverse events, indicating that curcumin has a good safety profile for long-term use in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin Supplementation (Meriva®) Modulates Inflammation, Lipid Peroxidation and Gut Microbiota Composition in Chronic Kidney Disease. Pivari, F., Mingione, A., Piazzini, G., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The effects of curcumin-containing supplementations on inflammatory markers and lipid profiles in patients with chronic kidney diseases: a systematic review and meta-analysis of randomized controlled trials. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Curcumin supplementation improves oxidative stress and inflammation biomarkers in patients undergoing hemodialysis: a secondary analysis of a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Recent Advances of Curcumin in the Prevention and Treatment of Renal Fibrosis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Oral supplementation of turmeric decreases proteinuria, hematuria, and systolic blood pressure in patients suffering from relapsing or refractory lupus nephritis: a randomized and placebo-controlled study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Curcumin Attenuates Both Acute and Chronic Immune Nephritis. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Renoprotective effect of the antioxidant curcumin: Recent findings. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Curcumin Supplementation (Meriva®) Modulates Inflammation, Lipid Peroxidation and Gut Microbiota Composition in Chronic Kidney Disease. [2022]