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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03569410
Enrollment
60
Registered
2018-06-26
Start date
2016-10-31
Completion date
2018-02-28
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoalbuminemia, Malnutrition, Peritoneal Dialysis Complication

Keywords

peritoneal dialysis, albumin, end stage renal disease

Brief summary

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.

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.

Interventions

BEHAVIORALincreased protein intake via natural foods

Patients had to eat 1.4g/kg/day of natural protein.

BEHAVIORALincrease 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.

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open-label prospective clinical trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum Albumin LevelsAfter three months of intervention.serum levels of albumin

Secondary

MeasureTime frameDescription
Serum Phosphorus levelsAt Month 0, 1, 2, and 3measured monthly
Goal protein intakeAt Month 0, 1, 2, and 3Via food diaries the total protein intake was calculated
Serum albumin levelsAt Month 0, 1, 2, and 3throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026