Randomized, Open Label, Controlled Clinical Trial of Oral Administration of an Egg Albumin-Based Protein Supplement to Patients on Continuous Ambulatory Peritoneal Dialysis

Abstract

Background/Aim Malnutrition is highly prevalent in patients on continuous ambulatory peritoneal dialysis (CAPD) and is a strong predictor of increased morbidity and mortality. Therefore, the aim of this study was to evaluate the effect of oral administration of an egg albumin-based protein supplement on the nutritional status of CAPD patients. Methods In this randomized, open label, controlled clinical trial, 28 CAPD patients were allocated to a study ( n = 13) or a control ( n = 15) group. Both groups received conventional nutritional counseling; the study group received, additionally, an oral egg albumin-based supplement. During a 6-month follow-up, all patients had monthly clinical and biochemical evaluations and quarterly assessments of adequacy of dialysis and nutrition. Results Serum albumin levels were not different between groups; however, a significant increase (baseline vs final) was observed in the study group (2.64 ± 0.35 vs 3.05 ± 0.72 g/dL) but not in the control group (2.66 ± 0.56 vs 2.80 ± 0.54 mg/dL). Calorie and protein intake increased more in the study group (calories 1331 ± 432 vs 1872 ± 698 kcal; proteins 1.0 ± 0.3 vs 1.7 ± 0.7 g/kg) than in the control group (calories 1423 ± 410 vs 1567 ± 381 kcal; proteins 1.0 ± 0.4 vs 1.0 ± 0.3 g/kg). Similarly, non-protein nitrogen appearance rate (nPNA) increased significantly more in the study (1.00 ± 0.23 vs 1.18 ± 0.35 g/kg/day) than in the control group (0.91 ± 0.11 vs 0.97 ± 0.14 g/kg/day). Triceps skinfold thickness (TSF) and midarm muscle area (MAMA) displayed a nonsignificant trend to a greater increase in the study group (TSF 16.7 ± 8.7 vs 18.3 ± 10.7 mm; MAMA 23.8 ± 6.2 vs 25.8 ± 5.9 cm2) than in controls (TSF 16.4 ± 5.7 vs 16.9 ± 7.0 mm; MAMA 28.7 ± 7.8 vs 30.0 ± 7.9 cm2). At the end of follow-up, the frequency of patients with moderate or severe malnutrition decreased 6% in the control group and decreased 28% in the study group. At the final evaluation, the most important predictors of serum albumin were the oral egg albumin-based supplement administration and protein intake ( p < 0.05); secondary predictors ( p = 0.06) were peritoneal transport rate and MAMA. Conclusions In the study group, oral administration of the egg albumin-based supplement significantly improved serum albumin, calorie and protein intake, and nPNA, and, compared to controls, this maneuver was associated with a trend to increased anthropometric parameters and improved Subjective Global Assessment evaluation. Oral administration of the albumin supplement and protein intake were the most significant predictors of serum albumin at the end of follow-up. This oral supplement may be a safe, effective, and cheap method to improve nutritional status in peritoneal dialysis patients.

British Dietetic Association evidence‐based guidelines for the protein requirements of adults undergoing maintenance haemodialysis or peritoneal dialysis

“…The PD studies in particular highlight that protein intake cannot be considered in isolation from energy intake. Nine of the twelve PD studies detailed energy intake allowing the inclusion of this detail when generating evidence statements (Chow et al ., ; Gonzalez‐Espinoza et al ., ; Jiang et al ., a,b; Lu et al ., ; Martin‐del‐Campo & Gonzalez‐Espinoza, ; Prasad et al ., ; Sutton et al ., ; Wang et al ., ). Of the twelve HD studies only three reported energy intakes, providing insufficient evidence for the development of practice guidelines (Araujo et al ., ; Ichikawa et al ., ; Lu et al ., ).…”

“…SIGN 2− There is limited weak evidence to suggest a protein intake of 1.37 g kg −1 with a dietary energy intake of 117 kJ kg −1 (28 kcal kg −1 ) is associated with malnutrition (Chow et al ., ). SIGN 3 There is limited weak evidence to suggest that no significant difference in SGA is achieved between a protein intake of 1.0 g kg −1 and 1.7 g kg −1 per day (Gonzalez‐Espinoza et al ., ). SIGN 1− The recommendation for protein requirements of stable adults undergoing maintenance PD is provided in Table .…”

“…). The remaining twelve studies included four randomised controlled trials (RCTs) (Chen et al ., ; Gonzalez‐Espinoza et al ., ; Jiang et al ., b; Sutton et al ., ), one quasi‐experimental study (Martin‐del‐Campo & Gonzalez‐Espinoza, ), one nonrandomised trial (Jiang et al ., ); one prospective cohort study (Chung et al ., ), two cross‐sectional studies (Wang et al ., ; Lu et al ., ) and three case series (Flanigan et al ., ; Chow et al ., ; Prasad et al ., ) (Table ). Most studies used nPNA and nPCR as markers of protein intake, with a very small number of studies using more detailed nutritional assessments such as food frequency questionnaires and diet records.…”

Dietary Egg Whites for Phosphorus Control in Maintenance Haemodialysis Patients: A Pilot Study

“…In our opinion, liquid egg whites are an improvement over sports protein bars which can be used as protein and energy supplements but which are problematic for patients with dentures and which do not allow alternate preparation methods (Meade 2007). In another study, egg albumin‐powder supplementation successfully increased serum albumin in peritoneal dialysis patients but unlike liquid egg whites, the egg albumin powder did not decrease serum phosphorus levels that may be related to phosphorus‐based additives (Gonzalez‐Espinoza et al 2005).…”

Briefly Noted

“…Oral supplementation with a powdered egg albumin‐based protein supplement (11 g protein twice a day) was associated with improved nutritional status in a 6‐month randomized controlled trial in 28 continuous ambulatory peritoneal dialysis (CAPD) patients (10). In the treated group, calorie intake and nitrogen appearance increased more than in the control group (541 versus 144 kCal; 0.18 versus 0.06 g/kg/day), while the frequency of moderate to severe malnutrition declined more (46% to 18% versus 33% to 27%).…”