Clinical trial NCT06381076: High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.
Official title: Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Kidney Disease 5D
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized comparator-controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: high-sensitivity C-reactive protein
timeFrame: 12 weeks or 84 days
Secondary outcomes:
measure: Advanced glycation end products
timeFrame: 12 weeks or 84 days
measure: fatty acid byproduct - 4-hydroxynon-enal
timeFrame: 12 weeks or 84 days
measure: fatty acid byproduct - malondialdehyde
timeFrame: 12 weeks or 84 days
measure: fatty acid byproduct - 8-F2 isoprostanes
timeFrame: 12 weeks or 84 days
measure: Klotho
timeFrame: 12 weeks or 84 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jeanette M Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References: