Trial Outcomes & Findings for High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis. (NCT NCT06381076)
NCT ID: NCT06381076
Last Updated: 2026-07-22
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
2026-07-22
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
|
|---|---|---|---|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Education level
Some high school
|
2 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Education level
High school graduate
|
6 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Education level
Some college, no degree
|
3 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Education level
Trade/Technical school
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Education level
Associate degree
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Education level
Bachelor's degree
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Dialysis Vintage (Dialysis vintage represents how long it has been since participants first started
|
4 years
STANDARD_DEVIATION 4 • n=9 Participants
|
8 years
STANDARD_DEVIATION 7 • n=27 Participants
|
6 years
STANDARD_DEVIATION 8 • n=267 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 |
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.
|
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.
|
|---|---|---|
|
High-sensitivity C-reactive Protein
|
5.09 milligrams per liter (mg/L)
Standard Deviation 2.43
|
-1.39 milligrams per liter (mg/L)
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: 12 weeks or 84 daysPopulation: Biospecimens were collected for this outcome; however, the laboratory assay was never performed due to logistical and resource constraints. Consequently, no data were generated for this variable, and no plans exist to run the assay in the future.
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 daysPopulation: Biospecimens were collected for this outcome; however, the laboratory assay was never performed due to logistical and resource constraints. Consequently, no data were generated for this variable, and no plans exist to run the assay in the future.
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.
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 |
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.
|
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.
|
|---|---|---|
|
Fatty Acid Byproduct - Malondialdehyde
|
-0.93 micromol per liter (µmol/L)
Standard Deviation 1.78
|
-0.98 micromol per liter (µmol/L)
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: 12 weeks or 84 daysPopulation: Biospecimens were collected for this outcome; however, the laboratory assay was never performed due to logistical and resource constraints. Consequently, no data were generated for this variable, and no plans exist to run the assay in the future.
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 daysBetween-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.
Outcome measures
| Measure |
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.
|
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.
|
|---|---|---|
|
Klotho
|
-0.94 picograms per milliliter (pg/mL)
Standard Deviation 4.27
|
-0.96 picograms per milliliter (pg/mL)
Standard Deviation 6.32
|
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