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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis; Renal Failure
• Interventions: Dietary Supplement: Whey protein isolate; Dietary Supplement: Soy protein isolate

• Registration Number: NCT05227755
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-08-05
• Primary Completion: 2023-08-31
• Study Completion: 2023-11-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whey protein isolate	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.
Soy protein isolate	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Uremic toxins - serum p-cresol sulfate and indoxyl sulfate	Up to 12 weeks of the study	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.
Malnutrition Inflammation Score	Up to 12 weeks of the study	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.
Isoflavones - Serum values of Genistin and Daidzin	Up to 12 weeks of the study	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.
Serum Amino acid profiles of essential and non-essential amino acids	Up to 12 weeks of the study	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States