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

NCT06381076 | Completed Phase 3 FDA Drug

• 1 other identifier: IRB202400087
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Advanced glycation end products

  12 weeks or 84 days

• fatty acid byproduct - 4-hydroxynon-enal

  12 weeks or 84 days

• fatty acid byproduct - malondialdehyde

  12 weeks or 84 days

• fatty acid byproduct - 8-F2 isoprostanes

  12 weeks or 84 days

• Klotho

  12 weeks or 84 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Drug: Liposomal curcumin

Control

PLACEBO COMPARATOR

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.

Drug: Food colorant

Interventions

Liposomal curcumin DRUG

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

Also known as: Manna Liposomal Curcumin

Intervention

Food colorant DRUG

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

Also known as: ChefMaster

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Jeanette M Andrade, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized comparator-controlled trial

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: February 3, 2025
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)