Chronic Kidney Disease 5D
Conditions
Brief 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. 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.
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.
Interventions
participants will consume the product ad libitum for the 24 treatments.
DRUGFood colorant
participants will consume the product ad libitum for the 24 treatments as a placebo.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant.
Intervention model description
Randomized comparator-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High-sensitivity C-reactive Protein | 12 weeks or 84 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advanced Glycation End Products | 12 weeks or 84 days | 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 |
| Fatty Acid Byproduct - 4-hydroxynon-enal | 12 weeks or 84 days | 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. |
| Fatty Acid Byproduct - Malondialdehyde | 12 weeks or 84 days | 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. |
| Fatty Acid Byproduct - 8-F2 Isoprostanes | 12 weeks or 84 days | 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. |
| Klotho | 12 weeks or 84 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeanette M Andrade, PhD
University of Florida
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Dialysis Vintage (Dialysis vintage represents how long it has been since participants first started | 6 years STANDARD_DEVIATION 8 |
| Education level Associate degree | 1 Participants |
| Education level Bachelor's degree | 1 Participants |
| Education level High school graduate | 1 Participants |
| Education level Some college, no degree | 7 Participants |
| Education level Some high school | 7 Participants |
| Education level Trade/Technical school | 5 Participants |
| Race/Ethnicity, Customized African American | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
None listed