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

NCT06381076 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease 5D

Interventions

DRUG

Liposomal curcumin

participants will consume the product ad libitum for the 24 treatments.

DRUG

Food colorant

participants will consume the product ad libitum for the 24 treatments as a placebo.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Jeanette M Andrade, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2025-05-13
Completion
2025-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06381076 on ClinicalTrials.gov