Ochoa 2017.

Trial name or title	Hypocaloric high‐protein enteral nutrition improves glucose management in critically ill patients
Methods	Study design: prospective, randomized, multicenter clinical trial Settings and countries: ICU of 7 academic centres at USA and Canada. In USA: Wake Forest University, Winston‐Salem, North Carolina; University of Kentucky, Lexington, Kentucky; Emory University, Atlanta, Georgia; Medicine, University of Chicago, Hinsdale, Illinois; Pulmonary Medicine, Regions Hospital, St Paul, Minnesota; Vanderbilt University, Nashville, Tennessee. In Canada: Kingston Hospital, Kingston, Ontario. Funding: Nestlé Health Science
Participants	Inclusion criteria Mechanically‐ventilated critically‐ill, obese and overweight participants requiring enteral nutrition. Exclusion criteria Not reported. Sample size: calculated sample size of 100 participants per group, based in a reduction of “out‐of‐range” glycaemic events and their standard deviation (glucose variability). Sample size of each arm of the study not reported. “Ninety‐eight subjects were randomized into the study at the time of interim analysis. Of these subjects, 40 had at least 5 days of data collected. The remaining subjects withdrew primarily due to removal of the feeding tube” Age (years, mean ± SD): Group 1: hypocaloric: 60.7 ± 15.07; Group 2: 62.6 ± 12.09 Sex (% of women): Group 1: 42.9; Group 2: 55.1 Primary disease of the participants. Not reported Disease severity: APACHE II score (mean ± SD). Group 1: 25.1 ± 9.0; Group 2: 26.3 ± 9.24 Nutrition status: BMI (kg/m2; mean ± SD). Group 1: 33.7 ± 4.57; Group 2: 32.5 ± 5.65 Mechanical ventilation: not available Comorbidities: not available Level of inflammation: not available
Interventions	Group 1 hypocaloric (n = not available) Enteral nutrition with a hypocaloric, high‐protein formulation Group 2 (n = not available) Enteral nutrition with a normocaloric, high‐protein formulation Co‐interventions In both study groups the quantity of the assigned formula was enough to provide 1.5 grams of protein/kg ideal body weight/day
Outcomes	Primary endpoint Number of glycaemic events in the first 7 days in ICU > 150 mg/dL or < 110 mg/dL Other endpoints Not defined, but reported results of mean daily glycaemia, blood glucose variability, hypoglycaemia (< 81 mg/dl) and insulin administered Outcomes and time points: not clearly defined Subgroups: not available
Starting date	Not available
Contact information	Juan.Ochoa@US.nestle.com. We contacted the study author and he replied that he would send us the study results.
Notes	An interim analysis was scheduled when 40 participants completed at least 5 days of data collection. All the current information comes from the abstract of a congress presentation (ASPEN, CNW, Orlando, Florida, 18 to 21 February, 2017) regarding the preliminary analysis of the intention‐to‐treat data.

Abbreviations:

APACHE = Acute Physiology And Chronic Health Evaluation II; BMI = Body Mass Index; ICU = Intensive Care Unit; REE = resting energy expenditure; SD = standard deviation; μg/kg/min = micrograms/kilograms/minute