Clinical trial NCT05227755: High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
Official title: High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Chronic Kidney Disease Requiring Chronic Dialysis
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: C-reactive protein
timeFrame: Up to 12 weeks of the study
measure: IL-6
timeFrame: Up to 12 weeks of the study
measure: Normalized protein catabolic rate
timeFrame: Up to 12 weeks of the study
Secondary outcomes:
measure: Isoflavones - Serum values of Genistin and Daidzin
timeFrame: Up to 12 weeks of the study
measure: Uremic toxins - serum p-cresol sulfate and indoxyl sulfate
timeFrame: Up to 12 weeks of the study
measure: Serum Amino acid profiles of essential and non-essential amino acids
timeFrame: Up to 12 weeks of the study
measure: Malnutrition Inflammation Score
timeFrame: Up to 12 weeks of the study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: