title: A khorasan wheat-based replacement diet improves risk profile of patients with type 2 diabetes mellitus (T2DM): a randomized crossover trial.
abstract: OBJECTIVE
  The aim of the present study was to examine whether a replacement diet with products made with organic ancient khorasan wheat could provide additive protective effects in reducing glucose, insulin, lipid and inflammatory risk factors, and in restoring blood redox balance in type 2 diabetes mellitus (T2DM) patients compared to diet with product made with modern organic wheat.
  
  
  METHODS
  We conducted a randomized, double-blinded crossover trial with two intervention phases on 21 T2DM patients (14 females, 7 males). The participants were assigned to consume products (bread, pasta, crackers and biscuits) made using semi-whole flour from organic wheat that was either from ancient khorasan wheat or modern control wheat for 8 weeks in a random order. An 8-week washout period was implemented between the interventions. Laboratory analyses were performed both at the beginning and at the end of each intervention phase.
  
  
  RESULTS
  The metabolic risk profile improved only after the khorasan intervention period, as measured by a reduction in total and LDL cholesterol (mean reduction: -3.7 and -3.4 %, respectively), insulin (-16.3 %) and blood glucose (-9.1 %). Similarly, there was a significant reduction in circulating levels of reactive oxygen species (ROS), vascular endothelial growth factor (VEGF) and interleukin-1ra, and a significant increase of total antioxidant capacity (+6.3 %). No significant differences from baseline were noted after the modern control wheat intervention phase. The change (from pre- to post-intervention) between the two intervention arms was significantly different (p < 0.05) for total and LDL-c, insulin and HOMA index.
  
  
  CONCLUSIONS
  A replacement diet with ancient khorasan wheat consumption provided additive protection in reducing total and LDL cholesterol, insulin, blood glucose, ROS production, and some inflammatory risk factors, which are all key factors warranting of control in secondary prevention of T2DM compared to a diet with products made with modern wheat.
authors: Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.
authors: Anne
authors: A
authors: Whittaker
authors: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. monicadinu89@gmail.com.
authors: Monica
authors: M
authors: Dinu
authors: Unit of Atherothrombotic Diseases, Careggi University Hospital, Florence, Italy.
authors: Francesca
authors: F
authors: Cesari
authors: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.|Unit of Atherothrombotic Diseases, Careggi University Hospital, Florence, Italy.
authors: Anna Maria
authors: AM
authors: Gori
authors: Department of Clinical and Experimental Biomedical Sciences, University of Florence, Florence, Italy.
authors: Claudia
authors: C
authors: Fiorillo
authors: Department of Clinical and Experimental Biomedical Sciences, University of Florence, Florence, Italy.
authors: Matteo
authors: M
authors: Becatti
authors: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.|Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy.
authors: Alessandro
authors: A
authors: Casini
authors: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.|Unit of Atherothrombotic Diseases, Careggi University Hospital, Florence, Italy.
authors: Rossella
authors: R
authors: Marcucci
authors: Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.
authors: Stefano
authors: S
authors: Benedettelli
authors: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.|Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy.|Don Carlo Gnocchi Foundation Italy, Onlus IRCCS, Florence, Italy.
authors: Francesco
authors: F
authors: Sofi
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy*; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D005433:Flour; D006801:Humans; D007328:Insulin / Q000097:blood; D007492:Iran; D008019:Life Style; D008297:Male; D008875:Middle Aged; D018384:Oxidative Stress; D017382:Reactive Oxygen Species / Q000378:metabolism; D012307:Risk Factors; D011795:Surveys and Questionnaires; D014908:Triticum / Q000145:classification*; D042461:Vascular Endothelial Growth Factor A / Q000378:metabolism
chemical_list: D001786:Blood Glucose; D008078:Cholesterol, LDL; D007328:Insulin; D017382:Reactive Oxygen Species; D042461:Vascular Endothelial Growth Factor A
keywords: Ancient wheat; Glycaemia; Inflammation cytokines; Khorasan wheat; Modern wheat; Organic wheat; Oxidative stress; Secondary prevention; Type 2 diabetes mellitus