title: Effects of single and long-term administration of wheat albumin on blood glucose control: randomized controlled clinical trials.
abstract: OBJECTIVE
  To examine the effects of single and long-term administration of wheat albumin (WA) on blood glucose levels and blood glucose control, respectively.
  
  
  METHODS
  Randomly arranged crossover trial for single administration in healthy subjects and double-blinded randomized controlled trial for long-term administration (3 months) in diabetic patients. In vitro alpha-amylase inhibitory activity of WA was also determined.
  
  
  METHODS
  Central Research Laboratories of Nisshin Flour Milling Co. Ltd. (Saitama, Japan) for single administration and Aiwa Clinic (Saitama, Japan) for long-term administration.
  
  
  METHODS
  A total of 12 healthy adult male volunteers for the single administration and 24 type II outpatient diabetics with mild hyperglycemia for the long-term administration.
  
  
  METHODS
  Subjects took soups containing 0, 0.25, 0.5, and 1.0 g WA before test meals for single administration, and patients took soups with or without 0.5 g WA before every meal for the long-term (3 months) administration.
  
  
  RESULTS
  In vitro alpha-amylase inhibitory activity of WA was 150 times that of wheat flour. In the single administration experiment, WA suppressed peak postprandial blood glucose levels in a dose-dependent manner: 31, 47, and 50% reduction after 0.25, 0.5, and 1.0 g administrations, respectively. In the long-term administration, 0.5 g of WA did not affect fasting blood glucose levels, whereas it reduced hemoglobin A1c levels. No significant adverse effects such as hypoglycemia or gastrointestinal disturbances were observed in the two experiments.
  
  
  CONCLUSIONS
  In the treatment of type II diabetic patients, WA might be a useful functional food, which, with diet and exercise, could help to improve blood glucose control without any critical adverse effects.
authors.affiliation: Nisshin Pharma Inc., Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Kodama
authors.forename: T
authors.initials: T
authors.lastname: Miyazaki
authors.forename: I
authors.initials: I
authors.lastname: Kitamura
authors.forename: Y
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Y
authors.initials: Y
authors.lastname: Namba
authors.forename: J
authors.initials: J
authors.lastname: Sakurai
authors.forename: Y
authors.initials: Y
authors.lastname: Torikai
authors.forename: S
authors.initials: S
authors.lastname: Inoue
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000418:Albumins / Q000008:administration & dosage* / Q000627:therapeutic use; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014908:Triticum; D000516:alpha-Amylases / Q000037:antagonists & inhibitors
chemical_list: D000418:Albumins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000516:alpha-Amylases