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

NCT05227755 | Completed

• 2 other identifiers: IRB202101921OCR41389
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; Chronic Kidney Disease Requiring Chronic Dialysis

Outcome Measures

Primary Outcomes (3)

• C-reactive protein

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

  Up to 12 weeks of the study

• IL-6

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

  Up to 12 weeks of the study

• Normalized protein catabolic rate

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

  Up to 12 weeks of the study

Secondary Outcomes (4)

• Isoflavones - Serum values of Genistin and Daidzin

  Up to 12 weeks of the study

• Uremic toxins - serum p-cresol sulfate and indoxyl sulfate

  Up to 12 weeks of the study

• Serum Amino acid profiles of essential and non-essential amino acids

  Up to 12 weeks of the study

• Malnutrition Inflammation Score

  Up to 12 weeks of the study

Study Arms (2)

Whey protein isolate

ACTIVE COMPARATOR

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

Dietary Supplement: Whey protein isolate

Soy protein isolate

EXPERIMENTAL

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

Dietary Supplement: Soy protein isolate

Interventions

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.

Soy protein isolate

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.

Whey protein isolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A third party vendor will provide the coded samples. The vendor will only reveal the actual products once the study has ended and analysis has occurred.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: February 7, 2022
• Study Start: August 5, 2022
• Primary Completion: August 31, 2023
• Study Completion: November 21, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)