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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569410
• Other study ID #: 11101
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: June 2018
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoalbuminemia
• Malnutrition
• Peritoneal Dialysis Complication

Intervention

Behavioral:
• increased protein intake via natural foods
Patients had to eat 1.4g/kg/day of natural protein.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Riverside Medical Center	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S1-140. Erratum in: Am J Kidney Dis 2001 Oct;38(4):917. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Albumin Levels	serum levels of albumin	After three months of intervention.
Secondary	Serum Phosphorus levels	measured monthly	At Month 0, 1, 2, and 3
Secondary	Goal protein intake	Via food diaries the total protein intake was calculated	At Month 0, 1, 2, and 3
Secondary	Serum albumin levels	throughout the study	At Month 0, 1, 2, and 3