Trial Outcomes & Findings for High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis. (NCT NCT06381076)
NCT ID: NCT06381076
Last Updated: 2026-06-01
Results Overview
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.
COMPLETED
PHASE3
39 participants
12 weeks or 84 days
2026-06-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
changed hemodialysis facility
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
received kidney transplant
|
1
|
0
|
Baseline Characteristics
High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.
Baseline characteristics by cohort
| Measure |
Intervention
n=15 Participants
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.
|
Control
n=16 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
28 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
14 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
17 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
21 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=48 Participants
|
|
Education level
Some high school
|
2 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=48 Participants
|
|
Education level
High school graduate
|
6 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=48 Participants
|
|
Education level
Some college, no degree
|
3 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
10 Participants
n=48 Participants
|
|
Education level
Trade/Technical school
|
2 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=48 Participants
|
|
Education level
Associate degree
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Education level
Bachelor's degree
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Dialysis Vintage (Dialysis vintage represents how long it has been since participants first started
|
4 years
STANDARD_DEVIATION 4 • n=24 Participants
|
8 years
STANDARD_DEVIATION 7 • n=24 Participants
|
6 years
STANDARD_DEVIATION 8 • n=48 Participants
|
PRIMARY outcome
Timeframe: 12 weeks or 84 daysBetween-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.
Outcome measures
| Measure |
Intervention
n=15 Participants
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.
|
Control
n=16 Participants
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.
|
|---|---|---|
|
High-sensitivity C-reactive Protein
|
11.16 milligrams per liter (mg/L)
Standard Deviation 2.6
|
11.84 milligrams per liter (mg/L)
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 12 weeks or 84 daysPopulation: 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
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks or 84 daysbaseline to end line in the concentration of fatty acid byproduct - 4-hydroxynon-enal between the control and intervention group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks or 84 daysBetween-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.
Outcome measures
| Measure |
Intervention
n=15 Participants
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.
|
Control
n=16 Participants
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.
|
|---|---|---|
|
Fatty Acid Byproduct - Malondialdehyde
|
1.99 micromol per liter (µmol/L)
Standard Deviation 0.28
|
1.78 micromol per liter (µmol/L)
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 12 weeks or 84 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks or 84 daysPopulation: 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.
baseline to end line in the concentration of klotho between the control and intervention group.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place