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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227755
• Other study ID #: IRB202101921
• Secondary ID: OCR41389
• Status: Completed
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: November 21, 2023

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 21, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Inflammation
• Kidney Diseases
• Renal Failure
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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