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

Description

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.

Conditions

Chronic Kidney Disease 5D

Study Overview

Study Details

Study overview

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.

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

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

Condition
Chronic Kidney Disease 5D
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Jeanette M Andrade, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2025-12