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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal curcumin | Drug | participants will consume the product ad libitum for the 24 treatments. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanette M Andrade, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Liposomal curcumin: participants will consume the product ad libitum for the 24 treatments. |
| FG001 | 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. Food colorant: participants will consume the product ad libitum for the 24 treatments as a placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Liposomal curcumin: participants will consume the product ad libitum for the 24 treatments. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | milligrams per liter (mg/L) | 12 weeks or 84 days |
|
12 weeks or 84 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Liposomal curcumin: participants will consume the product ad libitum for the 24 treatments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeanette Andrade | University of Florida | 3522943975 | jandrade1@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 28, 2024 | Apr 13, 2026 | Prot_SAP_ICF_000.pdf |
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Randomized comparator-controlled trial
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Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant.
| Food colorant | Drug | participants will consume the product ad libitum for the 24 treatments as a placebo. |
|
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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 |
| Klotho | baseline to end line in the concentration of klotho between the control and intervention group. | 12 weeks or 84 days |
| received kidney transplant |
|
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. Food colorant: participants will consume the product ad libitum for the 24 treatments as a placebo. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Dialysis Vintage (Dialysis vintage represents how long it has been since participants first started | Mean | Standard Deviation | years |
|
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. Food colorant: participants will consume the product ad libitum for the 24 treatments as a placebo. |
|
|
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| Secondary | 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 | Biospecimens were collected for this outcome; however, analysis was not conducted due to logistical/resource constraints. Therefore, 0 participants were included in the analysis for this outcome | Posted | 12 weeks or 84 days |
|
|
| Secondary | 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. | Not Posted | 12 weeks or 84 days | Participants |
| Secondary | 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. | Posted | Mean | Standard Deviation | micromol per liter (µmol/L) | 12 weeks or 84 days |
|
|
|
|
| Secondary | 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. | Biospecimens were collected for this outcome; however, analysis was not conducted due to logistical/resource constraints. Therefore, 0 participants were included in the analysis for this outcome. | Posted | 12 weeks or 84 days |
|
|
| Secondary | Klotho | baseline to end line in the concentration of klotho between the control and intervention group. | Biospecimens were collected for this outcome; however, analysis was not conducted due to logistical/resource constraints. Therefore, 0 participants were included in the analysis for this outcome. | Posted | 12 weeks or 84 days |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. Food colorant: participants will consume the product ad libitum for the 24 treatments as a placebo. | 0 | 16 | 0 | 16 | 0 | 16 |
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