Patients on dialysis received no nutritional benefit from daily energy-dense supplements
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For patients on hemodialysis, daily receipt of an oral fat-based energy-dense supplement had no clinically significant impact on nutritional status, results of a randomized controlled trial showed.
“Adequate dietary energy intake is necessary to maintain nitrogen balance and body composition in maintenance hemodialysis patients. Low dietary energy intake
(<30kcal/kg/d) is associated with a higher risk of mortality,” Yaya Yang, MS, of the National Clinical Research Center of Kidney Diseases in Guangzhou, China, and colleagues wrote. “However, anorexia, comorbidities, and prescribed dietary restrictions make it challenging for maintenance hemodialysis patients to achieve adequate energy intake, which contributes to poor nutritional status. The guidelines recommended nutritional interventions in maintenance hemodialysis patients. However, evidence regarding the effects of oral nutritional supplements on the nutritional status of such patients is limited and inconsistent.”
To investigate whether supplementation benefits this patient population, researchers randomized 240 patients to receive either 300 kcal daily of an oral fat-based energy-dense supplement or routine care for 12 weeks. Both groups were provided with dietary advice, but the control group received no nutritional supplementation. Patients with diabetes were excluded because the product manual from the company that manufactures the supplements (Fresubin) cautioned against excessive fat intake due to its impact on insulin sensitivity, according to the researchers.
Change in phase angle
“Although there are a number of indicators of nutritional status, including serum albumin, [BMI], and grip strength, no single parameter can indicate the overall nutritional status of maintenance hemodialysis patients,” Yang and colleagues wrote. “Recently, bioelectrical impedance analysis (BIA), has become a commonly used means of estimating body composition and monitoring nutritional status. Resistance (R) and reactance (Xc), obtained from BIA, were used to calculate the phase angle by the following equation: phase angle (°) = arctangent (Xc/R) × (180/). Although the biological meaning of phase angle is not clearly understood, it is thought to be a measure of cell integrity and body cell mass, and can reflect the nutritional status.”
In addition to considering changes in phase angle between groups, researchers also assessed changes in quality of life in 19 domains and the occurrence of adverse events.
After 12 weeks, Yang and colleagues found the mean energy intakes from food in the control and intervention groups were 23 kcal per kg per day and 23.2 kcal per kg per day, respectively, with the oral nutritional supplement providing an additional energy intake of 4.9 kcal per kg per day.
Impact of nutritional supplementation
Results showed no significant differences in the change in phase angle between the intervention and control groups, as well as no between-group differences in quality of life.
Adverse events were reported in 19% of patients in the control group and in 33% of patients in the intervention group and were most commonly gastrointestinal problems. Mean treatment adherence in the intervention group was 88%, with patients indicating adverse events and dislike of the taste of the supplement as the primary reasons for non-adherence.
“In this randomized controlled trial, 12 weeks of consumption of an oral, fat-based energy-dense supplement did not cause a significant improvement in phase angle in non-diabetic maintenance hemodialysis patients,” Yang and colleagues concluded of the findings. “Compared with the control group, this nutritional intervention may improve BMI, serum albumin and fat tissue indices. However, the magnitudes of these changes were small, and therefore they may not be clinically significant. Furthermore, the results must be interpreted with caution because of the likelihood of type statistical errors from multiple comparisons. Therefore, the results of the present study should be regarded as hypothesis-generating.”
The researchers recommend longer-term clinical trials with larger sample sizes be conducted to further assess the impact of nutritional supplementation on patients receiving maintenance hemodialysis.
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