COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-03
Study Completion:2025-05-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06381076

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years old or older
  2. * diagnosed with stage 5 CKD.
  3. * receiving hemodialysis at least three months before the trial start date
  4. * All participants can provide signed informed consent, have no dietary restrictions, no food allergies, nor chewing/swallowing difficulties.
  1. * Adults with CKD stages 1-4.
  2. * Adults undergoing peritoneal dialysis.
  3. * Pregnant and/or lactating for the duration of the study as confirmed by the dialysis medical staff.
  4. * Use of other IP within 3 months of the initiation of the study.

Contacts and Locations

Principal Investigator

Jeanette M Andrade, PhD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32611
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Jeanette M Andrade, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2025-05-13

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2025-05-13

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Disease 5D