A standard enteral formula versus an iso-caloric lower carbohydrate/high fat enteral formula in the hospital management of adolescent and young adults admitted with anorexia nervosa: a randomised controlled trial.

BACKGROUND: The nutritional rehabilitation of malnourished patients hospitalised with anorexia nervosa is essential. The provision of adequate nutrition must occur, while simultaneously, minimising the risk of refeeding complications, such as electrolyte, metabolic, and organ dysfunction. The aim of this study was to compare the efficacy and safety of an iso-caloric lower carbohydrate/high fat enteral formula (28% carbohydrate, 56% fat) against a standard enteral formula (54% carbohydrate, 29% fat). METHODS: Patients (aged 15-25 years) hospitalised with anorexia nervosa were recruited into this double blinded randomised controlled trial. An interim analysis was completed at midpoint, when 24 participants, mean age 17.5 years (± 1.1), had been randomly allocated to lower carbohydrate/high fat (n = 14) or standard (n = 10) feeds. RESULTS: At baseline, there was no significant difference in degree of malnutrition, medical instability, history of purging or serum phosphate levels between the two treatment arms. A significantly lower rate of hypophosphatemia developed in patients who received the lower carbohydrate/high fat formula compared to standard formula (5/14 vs 9/10, p = 0.013). The serum phosphate level decreased in both feeds, however it decreased to a larger extent in the standard feed compared to the lower carbohydrate/high fat feed (standard feed 1.11 ± 0.13 mmol/L at baseline vs 0.88 ± 0.12 mmol/L at week 1; lower carbohydrate/high fat feed 1.18 ± 0.19 mmol/L at baseline vs 1.06 ± 0.15 mmol/L at week 1). Overall, serum phosphate levels were significantly higher in the lower carbohydrate/high fat feed compared with standard feed treatment arm at Week 1 (1.06 ± 0.15 mmol/L vs 0.88 ± 0.12 mmol/L, p < 0.001). There was no significant difference in weight gain, number of days to reach medical stability, incidence of hypoglycaemia, or hospital length of stay. CONCLUSIONS: The results of this study indicate that enteral nutrition provided to hospitalised malnourished young people with anorexia nervosa using a lower carbohydrate/high fat formula (28% carbohydrate, 56% fat) seems to provide protection from hypophosphatemia in the first week compared to when using a standard enteral formula. Further research may be required to confirm this finding in other malnourished populations. TRIAL REGISTRATION: ANZCTR, ACTRN12617000342314. Registered 3 March 2017, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000342314.

Patients hospitalised with anorexia nervosa require nutrition support as part of their treatment, whilst refeeding complications are prevented. Of particular concern, is the reintroduction of carbohydrate to malnourished patients, which has been proposed to cause a surge in insulin levels and disturbance in electrolytes, particularly a decrease in blood phosphate levels. This double-blinded randomised controlled trial measured the occurrence of low phosphate blood levels and other refeeding complications, in adolescent and young adult patients hospitalised with anorexia nervosa. These patients were provided either a lower carbohydrate/high fat feed (28% carbohydrate, 56% fat) or a standard enteral feed (54% carbohydrate, 29% fat). Fewer patients in the lower carbohydrate/high fat feed group (5/14) than standard feed group (9/10) developed a low phosphate level. There was no significant difference in weight gain, number of days to reach medical stability, occurrence of hypoglycaemia, or hospital length of stay.

Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa.

INTRODUCTION: Providing effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An 'underfeeding syndrome' can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15-25 years), hospitalised with AN. METHODS AND ANALYSIS: The study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters. ETHICS AND DISSEMINATION: The protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.

Harm minimization in severe and enduring anorexia nervosa.

For many sufferers of anorexia nervosa, the time course is long, and the prospect of disability and family burden great. This is all too often the case, even with early diagnosis and treatment. The term severe and enduring anorexia nervosa has been applied to these survivors. Yet, a majority of patients do eventually recover and, even where this is not the case, adaptive medical stability and function can be maintained despite alarming dilapidation. Managing the years of illness so as to have the best outcome physically and psychologically, even where full weight recovery does not occur, or has not yet occurred, is the topic of this article. Literature pertaining to harm minimization in chronic, severe, enduring, and long-standing anorexia nervosa was selectively reviewed using an Ovid data base and Google Scholar. The authors' own clinical experience over almost four decades in public and private hospital and community settings has also informed much of what has been written. The authors would like to think that it is possible to do better than the familiar injunction (variously attributed to Hippocrates, Galen, and others) of 'primum non nocere'-although this is a good place to start.