The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients

June 22, 2018 updated by: Kaiser Permanente

The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients An Open-label Prospective Clinical Trial

This study is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. A total of 60 patients were enrolled, 16 chose to be in the natural food group and 44 in the supplement group. 4 were lost to follow-up in the supplement group leading to an n of 40. Both groups were educated by dietitians on how to increase their protein intake to a goal of 1.4g/kg/day. The groups were followed for 3 months with protein intake calculated according to the patient's food diaries. Patient demographics and characteristics were compared in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective open label clinical trial comparing serum albumin levels and total protein intake in the peritoneal dialysis patient population. Two treatment groups were established: a natural food group who was instructed by their dietician in how to reach their goal protein intake through purely increasing the consumption of natural foods rich in protein versus a protein supplement group who was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake. To increase compliance, patients were allowed to choose which treatment group they wanted to participate in. Patients, however, were not allowed to change groups during the study.

At the initiation of the study patients were asked to record food diaries so the dietician can calculate their baseline protein intake. Each patient had an assigned dietician who met with the patient monthly. The food diaries were collected during their monthly visits. Patients were also randomly called and asked to give their food intake during the last 24 hours in order to minimize recall bias. Each month the participant's dietician calculated their protein intake deficit and educated the patient on how to increase their protein intake to reach their goal of 1.4g/kg/day. The recommended protein intake for peritoneal dialysis patients is between 1.2 to 1.5 g/kg/day. Therefore, a goal of 1.4g/kg/day was set, which is at the higher end of the goal range in order to ensure an adequately high protein intake.

The patient's serum albumin levels, phosphate levels, kt/v, and total protein intake were recorded at baseline, month 1 (M1), month 2 (M2), and month 3 (M3). Furthermore, all major comorbidities in each patient were recorded and compared. Data was extracted from the electronical medical record system and entered into a password protected file. This data was then analyzed.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Riverside, California, United States, 92505
        • Kaiser Permanente Riverside Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 years
  • Initiation of peritoneal dialysis for at least a one-month time period, with the expectation to stay on peritoneal dialysis for the next 3 months
  • Independence with all activities of daily living (especially being able to cook)

Exclusion Criteria:

  • Age under 18 years
  • Expectation of termination of peritoneal dialysis within 3 months of entering the study
  • Life expectancy less than three months
  • Termination of life or peritoneal dialysis during the study period
  • Patient refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supplement Group
The protein supplement group was instructed by their dietician in how many protein supplements to consume in addition to their natural food intake in order to reach their goal protein intake.
Behavioral: increase protein intake via protein supplements
Patients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake.
Experimental: Natural Food Group
The Natural food group was instructed by their dietician in how much additional protein rich foods to eat in order to reach their goal protein intake.
Behavioral: increased protein intake via natural foods
Patients had to eat 1.4g/kg/day of natural protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Albumin Levels
Time Frame: After three months of intervention.
serum levels of albumin
After three months of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Phosphorus levels
Time Frame: At Month 0, 1, 2, and 3
measured monthly
At Month 0, 1, 2, and 3
Goal protein intake
Time Frame: At Month 0, 1, 2, and 3
Via food diaries the total protein intake was calculated
At Month 0, 1, 2, and 3
Serum albumin levels
Time Frame: At Month 0, 1, 2, and 3
throughout the study
At Month 0, 1, 2, and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Susan Sun, MD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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