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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peritoneal Dialysis Complication, Hypoalbuminemia, Malnutrition

Intervention / Treatment
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* Behavioral: increased protein intake via natural foods
* Behavioral: increase protein intake via protein supplements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label prospective clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement Group<br>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<br>* Patients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake.<br>|
| Experimental: Natural Food Group<br>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<br>* Patients had to eat 1.4g/kg/day of natural protein.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritoneal dialysis, albumin, end stage renal disease