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

NCT ID: NCT03569410

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-02-28

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.

Conditions

Peritoneal Dialysis Complication; Hypoalbuminemia; Malnutrition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

increase protein intake via protein supplements

Intervention Type: BEHAVIORAL

Patients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake.

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.

Group Type: EXPERIMENTAL

increased protein intake via natural foods

Intervention Type: BEHAVIORAL

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

Interventions

increased protein intake via natural foods

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Riverside Medical Center

Riverside, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23580797 (View on PubMed)

Cano N, Fiaccadori E, Tesinsky P, Toigo G, Druml W; DGEM (German Society for Nutritional Medicine); Kuhlmann M, Mann H, Horl 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. doi: 10.1016/j.clnu.2006.01.023. Epub 2006 May 12.

Reference Type: BACKGROUND

PMID: 16697495 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 10895784 (View on PubMed)

Other Identifiers

11101

Identifier Type: -

Identifier Source: org_study_id