A replacement KAMUT khorasan wheatbased diet improves the risk profile of patients with type 2 diabetes mellitus (T2DM): a randomized cross-over trial

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Gori AM 2, Fiorillo C 3, Becatti M 3, Casini A 2, Marcucci R 2, Benedettelli S 1, Sofi F 2 1

Department of Experimental and Clinical Medicine, University of Florence; Careggi University

1 A replacement KAMUT khorasan wheatbased diet improves the risk profile of patients with type 2 diabetes mellitus (T2DM): a randomized cross-over trial Whittaker A 1, Dinu M 2, Cesari F 2, Gori AM 2, Fiorillo C 3, Becatti M 3, Casini A 2, Marcucci R 2, Benedettelli S 1, Sofi F 2 1 Department of Agrifood Production and Environmental Sciences, University of Florence; 2 Department of Experimental and Clinical Medicine, University of Florence; Careggi University Hospital, Florence, Italy; 3 Department of Clinical and Experimental Biomedical Sciences, University of Florence

3 Characteristics of modern wheat High production. Maximum utilization of high energy input in specialized agricultural systems. Selection for technological quality of gluten proteins. Reduction in certain qualitative aspects (reduction in biodiversity of secondary metabolites). Currently, there is a renewed interest in old varieties (defined as varieties in existence prior to intensive selection for gluten quantity and quality) of Triticum aestivum and T. durum and T. spp turanicum, which represent a valuable source of biodiversity in functional components.

4 Healthy eating pyramid Harvard School of Public Health

5 KAMUT products and CV health

6 Kamut products and CV health KAMUT khorasan wheat control Bio wheat 10% 5% 0% % +1.0 % -5% -10% -15% -20% % % % % % ROS lymphocytes ROS monocytes BODIPY lymphocytes BODIPY monocytes

7 KAMUT products and CV health Variable Glucose, mg/dl Insulin, mg/dl Total cholesterol mg/dl LDL cholesterol, mg/dl Kamut Control p Pre Post change Pre Post change 100 ( ) 14.6 ( ) 171 ( ) 88.5 ( ) 92 ( ) -8 (-13.6; -2.3) ( (-5.9; ) 1.2) ( (-17.4; ) 5.8) -7.2 (-10.7; ( ) 3.7) 95.5 ( ) 97 ( ) 1.5 (-1.8; 4.9) ( ) 13.1 ( ) -0.6 (-2.6; 1.5) ( ) < ( ) ( ) 91.1 ( ) p 5 (-2.8; 12.9) (-3.3; 6.5) 0.5 HDL cholersterol, mg/dl 54.9 ( ) 53.6 ( ) -1.3 (-4.5; 2.8) ( ) 54.5 ( ) -1.4 (-5.1; 2.3) 0.4 Triglycerides mmol/l ( ) ( ) -5.6 (-12.3; 1.7) ( ) ( ) 7.2 (-5.5; 19.9) 0.2 Na, meq/l ( ) ( ) -0.4 (-1.1; 0.4) ( ) ( ) 0.1 (-0.7; 0.9) 0.8 K, meq/l 4.34 ( ) 4.44 ( ) 0.10 (-0.08; 0.3) ( ) 4.26 ( ) (-0.2; 0.08) 0.5 Mg, mg/dl 1.97 ( ) 2.02 ( ) 0.05 (0.004; 0.1) ( ) 1.82 ( ) (-0.49; 0.04) 0.09 P, mg/dl 3.37 ( ) 3.46 ( ) 0.09 (-0.04; 0.2) ( ) 3.46 ( ) 0 (-0.1; 0.1) 0.9 Fe, μg/dl 83.9 ( ) 89.9 ( ) 6 (-6.3; 8.3) ( ) 95.5 ( ) 8.2 (-9.8; 26) 0.3

8 Diabetes and diet Diet is thought to be one of the modifiable risk factors for the development of type 2 diabetes mellitus. An increasing interest in modifying the global risk profile of patients with diabetes through modification of dietary habits has been reported in recent years.

9 Aim To examine whether a replacement diet with KAMUT khorasan products could provide additive protective effects in reducing lipid, oxidative and inflammatory risk factors in diabetes mellitus (DM) patients

Study population 21 patients with a diagnosis of type 2

mellitus On treatment with antidiabetic drugs Exclusion

diabetes Clinical manifestations of CVD Celiac disease,

10 Study population 21 patients with a diagnosis of type 2 diabetes Inclusion criteria: Diagnosis of type 2 diabetes mellitus On treatment with antidiabetic drugs Exclusion criteria: Micro and/or macrovascular complications of diabetes Clinical manifestations of CVD Celiac disease, gluten-sensitivity or wheat allergy Inflammatory bowel disease Alcohol abusers

11 Study population 21 patients with a diagnosis of type 2 diabetes Variable Age, yrs, median (range) 65 (42-84) Males/Females 14 / 7 Body Mass Index, kg/m 2, mean ± SD 27.9 ± 4 Hypertension, n (%) 8 (38.1%) Smoking habit, n (%) 5 (23.8%) Dyslipidemia, n (%) 7 (33.3%)

12 8 weeks Kamut 8 weeks Kamut Control Control Wash-out Study design T0 Group A (n=11) Group B (n=10) T1 T2 Group B (n=10) Group A (n=11)

Material and methods Participants in both

150 g per day of bread, 250 g per week of

13 Material and methods Participants in both groups received 500 g per week of pasta, 150 g per day of bread, 250 g per week of crackers and 250 g per week of biscuits for a period of 8 weeks. All participants were not permitted to eat other grains products The control group consisted of organic semi-whole wheat grain products, locally grown

14 Material and methods Biochemical profile Lipid profile White blood cells Serum electrolytes Liver enzymes Creatinine Total cholesterol LDL-cholesterol HDL-cholesterol Triglycerides Conventional methods Conventional methods Glucometabolic profile Fasting glucose Insulin HOMA-index Conventional methods Inflammatory profile Pro- and antiinflammatory cytokines Multiplex beadbased assay (Bioplex) Oxidative profile TBARs ROS Chemiluminescence assay, Flow cytometry

15 Characteristic of study population Baseline characteristics Variable Group A (n=11) Group B (n=10) P value Age, yrs 65 (44-76) 68 (42-84) 0.4 BMI, kg/m ( ) 28.5 ( ) 0.3 Females, n 4/11 3/ Hypertension, n 4/11 4/ Smoking habit, n 3/11 1/ Dyslipidemia, n 4/11 3/ Diet score* 10 ± ± *Adherence score to Mediterranean diet

16 Results Lipid profile LDL-cholesterol, mg/dl 120 p= % 118,5 p= % 114,2 111, ,8 100 Kamut Pre Post Control General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

17 Results Lipid profile Total cholesterol, mg/dl p=0.04 p= % +3% General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

18 Results Glucometabolic profile Fasting blood glucose, g/l 180 p=0.04 p= % +3.5% Kamut Control Pre Post General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

19 Results Glucometabolic profile Insulin, U/L 18 p=0.04 p= ,7-16.3% +11.9% 14 13, ,3 11,8 10 Kamut Control Pre Post General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

20 Results Glucometabolic profile HOMA-index 8 p=0.04 p= , % 4, % 3,89 4,58 2 Kamut Control Pre Post General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

RFU Results Oxidative stress ROS Monocytes p=0.002-24.7% -7% p=0.

21 RFU Results Oxidative stress ROS Monocytes p= % -7% p=0.3 General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

22 RFU 3500 Results Oxidative stress ROS Granulocytes p=0.005 p= ,9-18.4% 2846,3-7% 2916, , Kamut Control Pre Post General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

23 Results Inflammatory parameters VEGF, pg/ml ,5 p= % p=0.3-11% ,5 125,8 128,1 100 Kamut Control Pre Post General linear model adjusted for age, gender, BMI, hypertension, diet score, and anti-diabetic drugs

24 Conclusion In the present study we observed that a replacement diet with KAMUT Khorasan products helps patients with a diagnosis of type 2 diabetes to improve their cardiovascular risk profile. This evidence could be of high clinical relevance for reducing the occurrence of a cardiovascular event in these patients

25 Of interest It is of great interest that the intake of health-promoting properties can be accomplished in the form of a basic staple food choice, such as wheat, which form the basis of the Mediterranean dietary pyramid. The positive effects were not attributable to the fact that KAMUT khorasan was organic semi-whole wheat since the modern durum and soft wheat controls were also cultivated in organic agriculture. The health benefits derived from khorasan are likely attributable, not to single components in isolation, but to potential synergistic effects of numerous components. The positive effects (inflammation in particular) may reside in the existence of novel secondary metabolite molecules or specific polyphenol isoforms that may contain signalling capacities not evident in the conventional varieties

IL PANE TOSCANO FA BENE? STUDIO DI INTERVENTO

IL PANE TOSCANO FA BENE? STUDIO DI INTERVENTO Sofi F, Cesari F, Gori AM, Mannini L, Ghiselli L^, Benedettelli S^, Vecchio V^, Abbate R, Gensini GF Department of Medical and Surgical Critical Care, Thrombosis