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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-05

Study Completion Date

2023-11-21

Brief Summary

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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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Detailed Description

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Conditions

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Renal Failure Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Whey protein isolate

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

Group Type ACTIVE_COMPARATOR

Whey protein isolate

Intervention Type 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.

Soy protein isolate

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

Group Type EXPERIMENTAL

Soy protein isolate

Intervention Type 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.

Interventions

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Soy protein isolate

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

Intervention Type DIETARY_SUPPLEMENT

Whey protein isolate

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No