High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Dietary supplement: Whey protein isolate; Dietary supplement: Soy protein isolate

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years old or older
• diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
• 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
• All participants have the ability to provide signed informed consent
• have not been newly diagnosed
• not present with symptomatic infection of COVID-19
• have no dietary restriction
• no food allergies
• no chewing/swallowing difficulties

Exclusion Criteria:

• CKD patient stages 1-4.
• CKD patient undergoing peritoneal hemodialysis.
• In isolation due to COVID-19 or other infectious disease
• Adult pregnant and/or lactating for the duration of the study.
• Any other renal disease autoimmune or otherwise.
• Use of other IP within 3 months prior of the eligibility screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whey protein isolate; Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.	Dietary supplement: Whey protein isolate; Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.
Experimental: Soy protein isolate; Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.	Dietary supplement: Soy protein isolate; Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.	Up to 12 weeks of the study
IL-6	Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.	Up to 12 weeks of the study
Normalized protein catabolic rate	Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.	Up to 12 weeks of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isoflavones - Serum values of Genistin and Daidzin	Collection of serum isoflavones (genistin and daidzin) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via HPLC.	Up to 12 weeks of the study
Uremic toxins - serum p-cresol sulfate and indoxyl sulfate	Collection of serum uremic toxins (p-cresol sulfate and indoxyl sulfate) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via LC/MS.	Up to 12 weeks of the study
Serum Amino acid profiles of essential and non-essential amino acids	Collection of serum amino acid profile of essential and non-essential amino acids to identify a change from pre-post to analyze the effect amino acids had on inflammation markers that will be assessed via LC/MS.	Up to 12 weeks of the study
Malnutrition Inflammation Score	Assessment of malnutrition at baseline and post-intervention to determine nutritional status. There are a total of 10 questions that participants will answer. Scores are from as low as 0 to as high for 3 for each question. A score of 0 indicates normal whereas a score of 30 indicates severe malnutrition.	Up to 12 weeks of the study

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation
• Other Study ID Numbers: IRB202101921; OCR41389 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No