The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients
| Status: | Completed |
|---|---|
| Conditions: | Food Studies |
| Therapuetic Areas: | Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/28/2018 |
| Start Date: | October 2016 |
| End Date: | February 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
