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

• ClinicalTrials.gov Identifier: NCT03569410
• Recruitment Status: Completed
• First Posted: June 26, 2018
• Last Update Posted: June 26, 2018
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peritoneal Dialysis Complication; Hypoalbuminemia; Malnutrition	Behavioral: increased protein intake via natural foods; Behavioral: increase protein intake via protein supplements	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open-label prospective clinical trial.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Natural Protein vs. Protein Supplements on Peritoneal Dialysis Patients An Open-label Prospective Clinical Trial
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Serum Albumin Levels [ Time Frame: After three months of intervention. ]
   serum levels of albumin

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Kaiser Permanente Riverside Medical Center

Riverside, California, United States, 92505

Sponsors and Collaborators

Kaiser Permanente

Investigators

• Principal Investigator: Susan Sun, MD; Kaiser Permanente

More Information

Publications:

Jeloka TK, Dharmatti G, Jamdade T, Pandit M. Are oral protein supplements helpful in the management of malnutrition in dialysis patients? Indian J Nephrol. 2013 Jan;23(1):1-4. doi: 10.4103/0971-4065.107185.

Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W; DGEM (German Society for Nutritional Medicine), Kuhlmann M, Mann H, Hörl WH; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Adult renal failure. Clin Nutr. 2006 Apr;25(2):295-310. Epub 2006 May 12.

Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S17-S104. doi: 10.1053/ajkd.2000.v35.aajkd03517. Erratum in: Am J Kidney Dis 2001 Oct;38(4):917.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT03569410
• Other Study ID Numbers: 11101
• First Posted: June 26, 2018
• Last Update Posted: June 26, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:

peritoneal dialysis; albumin; end stage renal disease

Additional relevant MeSH terms:

Hypoalbuminemia; Malnutrition; Nutrition Disorders; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases