CompletedNot Applicable

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

United States15 participantsStarted 2022-08-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

C-reactive protein

Timeframe: Up to 12 weeks of the study

IL-6

Timeframe: Up to 12 weeks of the study

Normalized protein catabolic rate

Timeframe: Up to 12 weeks of the study

Trial details

NCT IDNCT05227755

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Renal Failure trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.