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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Failure, Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Dietary Supplement: Soy protein isolate
* Dietary Supplement: Whey protein isolate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a 12-week interventional, double-blind randomized controlled crossover clinical trial designed to evaluate the impact of whey (control) and soy (intervention) protein isolate oral supplements on protein status and inflammation markers.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |