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OpenTrials
Completed

NCT Number: NCT05227755

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

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.

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Key information

Conditions

Renal Failure Chronic Kidney Disease Requiring Chronic Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soy protein isolate

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. C-reactive protein

    Time frame: Up to 12 weeks of the study

    Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.

  2. IL-6

    Time frame: Up to 12 weeks of the study

    Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.

  3. Normalized protein catabolic rate

    Time frame: Up to 12 weeks of the study

    Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.

Secondary outcomes

  1. Isoflavones - Serum values of Genistin and Daidzin

    Time frame: Up to 12 weeks of the study

    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.

  2. Uremic toxins - serum p-cresol sulfate and indoxyl sulfate

    Time frame: Up to 12 weeks of the study

    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.

  3. Serum Amino acid profiles of essential and non-essential amino acids

    Time frame: Up to 12 weeks of the study

    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.

  4. Malnutrition Inflammation Score

    Time frame: Up to 12 weeks of the study

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2022
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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