High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.

University of Florida

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease 5D

Treatments: Drug: Liposomal curcumin; Drug: Food colorant

Study type: Interventional

Funder types: Other

Identifiers

NCT06381076

IRB202400087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Liposomal curcumin

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Food colorant