Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis.

Chronic Kidney Disease 5D Clinical Trial

Official title:

Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381076
• Other study ID #: IRB202400087
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: Jeanette M Andrade, PhD
• Phone: 3522943975
• Email: jandrade1[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Liposomal curcumin
participants will consume the product ad libitum for the 24 treatments.
• Food colorant
participants will consume the product ad libitum for the 24 treatments as a placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high-sensitivity C-reactive protein	baseline to end line in the concentration of high-sensitivity C-reactive protein between the control and intervention group.	12 weeks or 84 days
Secondary	Advanced glycation end products	baseline to end line in the concentration of advanced glycation end products between the control and intervention group.	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.	12 weeks or 84 days
Secondary	fatty acid byproduct - malondialdehyde	baseline to end line in the concentration of fatty acid byproduct - malondialdehyde between the control and intervention group.	12 weeks or 84 days
Secondary	fatty acid byproduct - 8-F2 isoprostanes	baseline to end line in the concentration of fatty acid byproduct - 8-F2 isoprostanes between the control and intervention group.	12 weeks or 84 days
Secondary	Klotho	baseline to end line in the concentration of klotho between the control and intervention group.	12 weeks or 84 days