NCT05227755Completed
High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
Source: ClinicalTrials.gov · Last updated 10 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 21 Dec 2021
- Start date
- 5 Aug 2022
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- University of Florida
- Diseases
- Chronic kidney disease
- NCT number
- NCT05227755
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 5 Aug 2022 to the primary completion date, 31 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other IP within 3 months prior of the eligibility screening.
Other illness
- In isolation due to COVID-19 or other infectious disease
- Any other renal disease autoimmune or otherwise.
Other
- CKD patient stages 1-4.
- CKD patient undergoing peritoneal hemodialysis.
- Adult pregnant and/or lactating for the duration of the study.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.