• Siavash Babajafari, Abdollah Hojhabrimanesh, Zahra Sohrabi, Mehdi Ayaz, Ali Noorafshan, and Atefeh Akrami.
• Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
• Trials. 2018 Jun 4; 19 (1): 308.

BackgroundThere is controversy regarding whether increasing isolated soy protein (ISP) with or without flaxseed oil (FO), as functional foods, would lead to reduce muscle catabolism and cachexia in burn patients.MethodsOne hundred and eighty-eight patients were assessed for eligibility in this randomized controlled trial. Of these, seventy-three eligible patients (total burn surface area 20-50%) were randomly assigned to three groups, labeled as Control (wheat flour [WF] + corn oil [CO]), ISP + FO, and ISP + CO, to receive these nutrients for three weeks. Weight, body mass index (BMI), serum hepatic enzymes (alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase [ALP]), systemic inflammatory response syndrome (SIRS), 24-h urinary urea nitrogen excretion (UUN), serum creatinine, 24-h urinary creatinine (UUC) excretion, fasting blood sugar (FBS), triglyceride (TG), and cholesterol were measured.ResultsUsing analysis of covariance models in the intention-to-treat population (n = 73), we found that at three weeks, patients in the ISP groups had lost significantly less in weight and BMI compared to those in the control group (all P < 0.01). Nitrogen retention and serum creatinine (primary outcomes) increased significantly in the ISP groups compared with the control group. Even after controlling for potential covariates in ANCOVA models, changes in these indices were still statistically significant (P = 0.008 and P = 0.005 for nitrogen balance and serum creatinine, respectively). However, no such significant differences were found between the ISP groups. On the other hand, 24-h UUN, and UUC excretion, serum hepatic enzymes, FBS, TG, and cholesterol were not significant between the groups (P > 0.05).ConclusionISP and FO compared to WF and CO reduced muscle catabolism and increased body weight in burn patients.Trial RegistrationIranian Registry of Clinical Trials, IRCT2014051817740N1 . Registered on 27 June 2014.

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