title: Effect of soy protein supplementation in patients with chronic hepatitis C: a randomized clinical trial.
abstract: OBJECTIVE
  To evaluate the effects of soy supplementation on insulin resistance, fatty liver and alanine aminotransferase (ALT) levels in non-diabetic patients with chronic hepatitis C (CHC).
  
  
  METHODS
  In a prospective, randomized and single-blinded clinical trial, we compared patients with CHC who had casein as a supplement (n = 80) (control group), with patients who consumed a soy supplement diet (n = 80) [intervention group (IG)]. Both groups received 32 g/d of protein for 12 wk.
  
  
  RESULTS
  Patients' baseline features showed that 48.1% were overweight, 43.7% had abdominal fat accumulation, 34.7% had hepatic steatosis and 36.3% had an homeostasis model assessment index of insulin resistance (HOMA-IR) ≥ 3.0. Descriptive analysis showed that protein supplementation diet reduced hepatic steatosis in both groups; however, significant reductions in ALT levels occurred in the soy group. Multiple regression modeling indicated that in the presence of severe fibrosis (F3/F4), γ glutamyl transferase elevation and high density lipoprotein (HDL) reduction, the intervention group had 75% less chance of developing hepatic steatosis (OR= 0.25; 95% CI: 0.06-0.82) and 55% less chance of presenting with an ALT level ≥ 1.5 × the upper limit of normal (ULN) (OR = 0.45, 95% CI: 0.22-0.89). Soy treatment did not have any effect on insulin resistance (OR = 1.92; 95% CI: 0.80-4.83), which might be attributed to the fact that the HOMA-IR values at baseline in most of our patients were in the normal range. Advanced hepatic fibrosis, an ALT level > 1.5 × ULN and visceral fat were predictors of an HOMA-IR ≥ 3. The IG group had a reduced risk of an ALT level > 1.5 × ULN. An HOMA-IR ≥ 3.0 and HDL < 35 mg/dL were also risk factors for increased ALT.
  
  
  CONCLUSIONS
  Soy supplementation decreased ALT levels and thus may improve liver inflammation in hepatitis C virus (HCV) patients; it also reduced hepatic steatosis in a subgroup of patients but did not change insulin resistance. It should be considered in the nutritional care of HCV patients.
authors.affiliation: Postgraduate Course in Medicine and Health and Nutrition Science Department, Federal University of Bahia, Bahia 40110-150, Brazil. valdapm@hotmail.com
authors.forename: Lucivalda P M
authors.initials: LP
authors.lastname: Oliveira
authors.forename: Rosangela P
authors.initials: RP
authors.lastname: de Jesus
authors.forename: Ramona S S B
authors.initials: RS
authors.lastname: Boulhosa
authors.forename: Carlos Mauricio C
authors.initials: CM
authors.lastname: Mendes
authors.forename: Maria Cecilia
authors.initials: MC
authors.lastname: Gnoatto
authors.forename: Denise C
authors.initials: DC
authors.lastname: Lemaire
authors.forename: Maria Betania P
authors.initials: MB
authors.lastname: Toralles
authors.forename: Lourianne N
authors.initials: LN
authors.lastname: Cavalcante
authors.forename: Andre C
authors.initials: AC
authors.lastname: Lyra
authors.forename: Luiz G C
authors.initials: LG
authors.lastname: Lyra
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001938:Brazil; D019587:Dietary Supplements; D005234:Fatty Liver / Q000517:prevention & control / Q000821:virology; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D007333:Insulin Resistance; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D030262:Soybean Proteins / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D030262:Soybean Proteins; D000410:Alanine Transaminase