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

University of Florida

Status: Completed

Conditions: Renal Failure; Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Dietary Supplement: Soy protein isolate; Dietary Supplement: Whey protein isolate

Study type: Interventional

Funder types: Other

Identifiers

NCT05227755

OCR41389 (Other Identifier)

IRB202101921

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Whey protein isolate

Active Comparator group

Description:

Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Treatment:

Dietary Supplement: Whey protein isolate

Soy protein isolate

Experimental group

Description:

Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Treatment:

Dietary Supplement: Soy protein isolate