Comparing isolated soy protein with flaxseed oil vs isolated soy protein with corn oil and wheat flour with corn oil consumption on muscle catabolism, liver function, blood lipid, and sugar in burn patients: a randomized clinical trial.

BACKGROUND: There 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. METHODS: One 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. RESULTS: Using 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). CONCLUSION: ISP and FO compared to WF and CO reduced muscle catabolism and increased body weight in burn patients. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT2014051817740N1 . Registered on 27 June 2014.

The effect of isolated soy protein adjunctive with flaxseed oil on markers of inflammation, oxidative stress, acute phase proteins, and wound healing of burn patients; a randomized clinical trial.

INTRODUCTION: The objective was to determine the effect of isolated soy protein (ISP) and flaxseed oil (FO) on inflammatory and oxidative stress indices, acute phase proteins, and wound healing of burn patients. METHODS: One hundred 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 3 isocaloric groups, labeled as control (wheat flour+corn oil (CO)), ISP+FO, and ISP+CO, to receive these nutrients for 3 weeks. We used intention to treat analysis to overcome bias. Because of the large perturbation in water compartments, patients received nutrients from 4th to 25th day of admission. Serum high sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), superoxide dismutase (SOD), ferritin, albumin, and transferrin were measured. The wound area was evaluated by stereological test. RESULTS: During the 3-week intervention, hs-CRP (-19.4±5.6, -11.7±4.7µg/ml) and ferritin (-83.8±20.5, -80.1±19.6ng/ml) levels changes significantly reduced compared to the control group (P<0.05). MDA level (-0.05±0.21µmol/l) significantly decreased in group A (P<0/05) but was not significant in groups B and control (P>0.05). Albumin level (0.59±0.14, 0.30±0.12g/dl) significantly increased in group A compared to the control group (P<0.05), but no significant relationship was found between other groups (P>0.05). Transferrin level (4.9±3.6, 2.9±5.1g/dl) significantly increased in ISP groups compared to the control (P<0.05). SOD improved in all groups with no significant difference between them (P>0.05). The stereology examination showed significant improvement in wound healing in the ISP groups on days 22 and 25 compared to the control group. CONCLUSION: Nutritional supplements with ISP may attenuate post-burn oxidative stress and inflammation, leading to improved wound healing in burn patients. Flaxseed oil may not exert a beneficial effect over the ISP.