CloseIcon Close

Studies and regulatory

Glucagel studies and regulatory

Please find enclosed some informations regarding published studies and regarding regulatory updates of barley beta-glucan.

The EFSA scientific opinion (October 2009)

Barley beta-glucane helps to maintain a normal level of the good blood cholesterol

  • Substantiates barley beta-glucan Health Claim in Article 13 of EC Regulation 1924/2006

  • Panel concluded that barley beta-glucans are sufficiently characterized

  • Panel concluded that a cause and effect relationship has been established between the consumption of barley beta-glucan and reduction of blood cholesterol concentrations

  • Panel concluded normal blood cholesterol concentrations are beneficial to human health

  • Applies to barley beta-glucans naturally present in foods and those forms added to foods

  • The claim is for consumption of at least 3 grams of barley beta-glucan daily

  • Barley beta-glucan (3 grams) may be provided in one or more servings. One serving must provide at least 25% (1/4th) of the daily consumption requirement

  • Target population is adults with normal or mildly elevated blood cholesterol levels

  • Panel concluded that beta-glucans from barley and oat have similar effects on cholesterol

  • Augustin LS, Franceschi S, Jenkins DJA, Kendall CWC and CL Vecchia 2002. Glycemic index in chronic disease: A review. Eur. J. Clin. Nutr. 56: 1049-1071

  • Behall, KM, Scholfield, DJ and J Hallfrisch 2004a. Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am. J. Clin. Nutr. 80: 1185-1193

  • Behall, KM, Scholfield, DJ and J Hallfrisch 2004b. Lipids significantly reduced by diets containing barley in moderately hypercholesterolemic men. J. Amer. Coll. Nutr. 23: 55-62

  • Benton D and S Nabb. 2003: Carbohydrate, memory and mood. Nutrition Reviews 61: S61-S67.

  • Benton D, Ruffin M-P, Lassel T and S Nabb 2003. The delivery rate of dietary carbohydrates affects cognitive performance in both rats and humans. Psychopharmacology 166: 86-90

  • Bingham, SA, Day, NE, Luben, R et al. 2003. Dietary fibre in food and protection against colorectal cancer in the European prospective investigation into cancer and nutrition (EPIC): An observational study. Lancet 361: 1496-1501

  • Bourdon I, Yokoyama W, Davis P, Hudson P, Backus C, Richter R, Knuckles D, Schneeman et al 1999. Postprandial lipid, glucose, insulin and cholecystokinin responses in men fed barley pasta enriched with β-glucan Am. J. Clin. Nutr.69: 55-63

  • Brand-Miller JC 2003. Glycemic load and chronic disease. Nutr. Rev. 61: S49-S55

  • Brand-Miller JC, Hayne S, Petocz P and S Cloagiuri 2003. Low-glycemic index diets in the management of diabetes. Diabetes Care 26: 2261-2267

  • Burke, V, Hodgson, JM, Beilin, LJ, Giangiuloi, N, Rogers, P and IB Puddey 2001. Dietary protein and soluble fiber reduce ambulatory blood pressure in treated hypertensives. Hypertension 38: 821-826

  • Cavallero, A, Empilli, S, Brighenti, F and A M Stanca 2002: High (1-3,1-4)-b-D-glucan barley fractions in bread making and their effects on human glycemic response. J. Cereal Sci. 36: 59-66

  • Davis JM, Murphy EA, Brown AS, Carmichael MD, Ghaffar A and EP Mayer 2004. Effects of moderate exercise and oat β-glucan on innate immune function and susceptibility to respiratory infection. Am. J. Physiol. Regul. Integr. Physiol. 286: R366-R372

  • Dongowski, G, Huth, M, Gebhardt, E and W Flamme 2002. Dietary fiber-rich barley products beneficially affect the intestinal tract of rats. J. Nutr. 132:3704-14

  • Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP and DS Ludwig 2003. A reduced glycemic load diet in the treatment of adolescent obesity. Arch. Pediatr. Adolesc. Med. 157: 773-779

  • Estrada A, Yun C, van Kessel A, Li B, Huata S, Laarveld B. Immunomodulatory activities of oat β-glucan in vitro and in vivo. Microbial. Immunol. 1997 41: 991-998

  • Golay et al 1992 Diab. Res. Clin. Pract. 15: 135-142. The effect of muesli or cornflakes at breakfast on carbohydrate metabolism in type 2 diabetic patients

  • Gradman TJ, Laws A, Thompson LW and GM Reaven 1993. Verbal learning and/or memory improves with glycemic control in older subjects with non-insulin-dependent diabetes mellitus. J Am. Geriatr. Soc. 41:1305-12

  • Granfeldt Y, Liljeberg H, Drews A, Newman R Bjorck I 1994 Glucose and insulin responses to barley products: influence of food structure and amylose-amylopectin food structure. Am J Clin Nutr 59: 1075-1082

  • Hallfrisch, JG, Scholfield, DJ and KM Behall 2003. Comparison of glucose and insulin responses to barley and oats. Cer. Chem. 80:80-83

  • He, J, Streiffer, RH, Muntner, P, Krousel-Wood MA and PK Whelton 2004. Effect of dietary fiber intake on blood pressure: a randomised, double-blind, placebo-controlled trial. J Hypertension 22: 73-80

  • Holt, S, Brand, J, Soveny, C and J Hansky 1992. Relationship of satiety to postprandial glycemic, insulin and cholecystokinin responses. Appetite 18: 129-141

  • Holt, S.H.A.; Delargy, H.J.; Lawton, C.L.; Blundell, J.E. 1999: The effects of high-carbohydrate vs high -fat intake breakfasts on feelings of fullness and alertness, and subsequent food intake. International Journal of Food Sciences and Nutrition 50: 13-28.

  • Ikegami, S, Tomita, M, Honda, S, Yamaguchi, M, Mizukawa, R, Suzuki, Y, Ishi, K, Ohsawa, S, Kiyooka, N, Higuchi, M and S Kobayashi 1996. Effects of boiled barley rice feeding in hypercholesterolemic and normolipemic subjects. Plant Foods and Hum. Nutr. 49:317-328

  • Jang Y, Lee JH, Kim OY, Park HY, Lee SY 2001 Arterioscler Thromb Vasc Biol 21: 2065-2071 Consumption of whole grain and legume powder reduces insulin demand, lipid peroxidation and plasma homocysteine concentrations in pateints with coronary heart disease.

  • Jenkins AL, Jenkins DJA, Zdravkovic U, Wursch P and V Vuksan 2002. Depression of the glycemic index by high levels of β-glucan fiber in two functional foods tested in type 2 diabetes. J. Clin. Nutr. 56: 622-628

  • Jones, J.M. 2001: The benefits of eating breakfast cereals. Cereal Foods World 46: 461-467.

  • Kabir, M, Oppert, J-M, Vidal, H, Bruzzo, F, Fiquet, C, Wursch, P, Slama, G and SW Rizkalla 2002. Four-week low-glycemic index breakfast with a modest amount of soluble fibers in type 2 diabetic men. Metabolism 51: 819-826

  • Kanauchi, O, Iwanaga, T, Mitsuyama, K, Saiki, T, Tsuruta, O, Noguchi, K and A Toyonaga 1999. Butyrate from bacterial fermentation of germinated barley foodstuff preserves intestinal barrier function in experimental colitis in the rat model. J. Gastroint. Hepatol. 14:880-8

  • Kaplan, R.J.; Greenwood, C.E.; Winocur, G.; Wolever, T.M.S. 2000: Cognitive performance is associated with glucose regulation in healthy elderly persons and can be enhanced with glucose and dietary carbohydrates. American Journal of Clinical Nutrition 72: 825-836.

  • Key, TJ, Fraser, GE, Thorogood M et al. 1998. Mortality in vegetarians and non-vegetarians: A collaborative analysis of 8300 deaths among 76,000 men and women in five prospective studies. Public Health Nutrition 1: 33-41

  • Knuckles, BE, Hudson, CA and MM Chiu 1997. Effect of beta glucan barley fractions in high fibre bread and pasta. Cereal Foods World 42: 94-99

  • Koh-Bannerjee, P, Franz, M, Sampson, L, Liu, S, Jacobs, DR Jr, Spiegelman, D, Willett, W and E Rimm 2004. Changes in wholegrain, bran and cereal fiber consumption in relation to 8-y weight gain among men. Amer. J. Clin. Nutr. 80:1237-1245

  • Kushi, LH, Meyer, KA, and DR Jacobs 1999. Cereals, legumes, and chronic disease risk reduction: Evidence from epidemiologic studies. Amer. J. Clin. Nutr. 70: s451-8

  • Li, J, Kaneko, T, Qin, LQ, Wang, J and Y Wang 2003. Effects of barley intake on glucose tolerance, lipid metabolism and bowel function in women. Nutr 19:11-12, 926-929

  • Li, J, Wang, J, Kaneko, T, Qin, L-Q and A Sato 2004. Effects of fiber intake on the blood pressure, lipids and heart rate in Goto Kakizaki rats. Nutrition 20: 1003-7

  • Liljeberg H and Bjorck I 1994. Bioavailability of starch in bread products. Postprandial glucose and insulin responses in healthy subjects and in vitro resistant starch content. Eur J Clin Nutr 48: 151-163

  • Liljeberg, HGM, Granfeldt, YE and IME Björck 1996. Products based on a high fiber barley genotype, but not on common barley or oats, lower postprandial glucose and insulin responses in healthy humans. J. Nutr. 126: 458-466

  • Lipid Research Clinics Program, The Lipid Research Clinics Coronary Primary Prevention trial results. II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA 1984 251: 365-374

  • Liu, S, Willett, WC, Manson, JE, Hu, FB, Rosner, B and G Colditz 2003. Relation between changes in intakes of dietary fiber and grain products and changes in weight and development of obesity among middle-aged women. Amer. J. Clin. Nutr. 78: 920-7

  • Ludwig, DS, Majzoub, JA, Al-Zahrani, A, Dallal, GE, Blanco, I and SB Roberts 1999. High glycemic index foods, overeating and obesity. Pediatrics 103: e26

  • McIntosh, GH 1993. Colon cancer: dietary modifications required for a balanced protective diet. Prev. Med. 22:767-774

  • McIntosh, G 2001. Cereal foods, fibres and the prevention of cancers. Aust. J. Nutr. and Diet. 58:s35-48

  • McIntosh, GH, Whyte, J, McArthur, R and PJ Nestel 1991. Barley and wheat foods: influence on plasma cholesterol concentrations in hypercholesterolemic men. Am. J. Clin. Nutr. 53: 1205-9

  • Menelly GS, Cheung E, Tessier D, Yakura C and H Tuokko 1993. The effect of improved glycemic control on cognitive functions in the elderly patient with diabetes. J. Gerontol. 48:M117-21

  • Multiple Risk Factor Intervention Trial Research Group 1982. Multiple Risk Factor Intervention Trial. Risk factor changes and mortality results. JAMA 248: 1465-1477

  • Pick, ME, Hawrysh, ZJ, Gee, MI and E Toth 1998. Barley bread products improve glycemic control of type 2 subjects. Int. J. Food Sci. and Nutr. 49: 71-78

  • Pins, J, Geleva, D, Keenan, JM, Frazel, C, O’Connor, PJ and LM Cherney 2002. Do whole-grain oat cereals reduce the need for anti-hypertensive medications and improve blood pressure control? J. Fam. Pract. 51: 353-359

  • Rimm, EB, Ascherio, A, Giovanucci, E, Spiegelman, D, Stampfer, MJ and WC Willett 1996. Vegetable, fruit and cereal fiber intake and risk of coronary heart disease among men. JAMA 275: 447-541

  • Ripsin, CM, Keenan, JM, Jacobs, DR, Elmer, PJ, Welch, RR, Van Horn, L, Liu, K, Turnbull, WH, Thye, F, Kestin, M, Hegsted, M, Davidson, MH, Dugan, LD, Dehmark-Wahnefried, W and S Beling 1992. Oat products and lipid lowering: a meta-analysis. JAMA 267:3317-3325

  • Salmeron J, Ascherio, A, Rimm EB, Coldiz GA, Spiegelman D, Jenkins DJ, Stampfer MJ, Wing AL and Willet WC 1997a. Dietary fibre, glycaemic load and risk of NIDDM in men. Diabetes Care 20: 545-550

  • Salmeron J, Manson JE, Stampfer MJ, Coldiz GA, Wing AL and Willet WC. 1997b Dietary fibre, glycaemic load and risk of NIDDM in women. J Amer Med Assoc 277: 472-477

  • Slabber M, Barnard HC, Kuyl JM, Dannhauser, A and R Schall 1994. Effects of a low insulin-response, energy-restricted diet on weight loss and plasma insulin concentrations in hyperinsulinemic obese females. Am. J. Clin. Nutr. 60: 48-53

  • Slavin, JL 2005. Dietary fiber and body weight. Nutr. 21: 411-418

  • Smith, K, Queenan, K, Thomas, W, Fulcher, G and J Slavin 2004. Study of cholesterol-lowering effect of β-glucan from barley in hypercholesterolemic subjects. FASEB J. 18: A149

  • Speith LE, Harnish JD, Lenders CM, Raezer RB, Pereira MA, Hangen SJ and DS Ludwig 2000. A low glycemic index diet in the treatment of pediatric obesity. Arch. Pediatr. Adolesc. Med. 154: 947-951

  • Stampfer MJ, Hu FB, Manson JE, Rimm EB and WC Willett 2000. Primary prevention of cornoary heart disease in women through diet and lifestyle. New Engl. J. Med. 343: 16-22

  • US Food and Drug Administration 2006. Food Labelling: Health claims; Soluble dietary fiber from certain foods and coronary heart disease. USFDA Fed. Reg. 71(98), pp. 29248-29250

  • Warren, JM, Henry, CJK, and V. Simonite 2003. Low glycemic index breakfasts and reduced food intake in preadolescent children. Pediatrics 112: e414

  • Wolk, A, Manson, JE, Stampfer, MJ, Colditz, GA, Hu, FB, Speizer, FE, Hennekens, CH and WC Willett 1999. Long-term intake of dietary fiber and decreased risk of coronary heart disease among women. JAMA 281: 1998-2004

  • Yokoyama, W.H., Hudson, C.A., Knuckles, B.E., Chiu, M.C.M., Sayre, R.N., Turnlans, J.R. and B.O. Schneeman 1997: Effect of barley beta-glucan in durum wheat pasta on human glycemic response. Cereal Chem. 74: 293-296

  • Yoshizawa, M, Yokoyama, K Nakano, Y and H Nakamura 2004. Protective effects of barley and its hydrolysates on gastric stress ulcer in rats. Yakugaku Zasshi 124: 571-5

  • Yun CH, Estrada, A, van Kessel, A, Gajadhar, A, Redmond, M and B Laarveld 1997. b-(1-3, 1-4) oat β-glucan enhances resistance to Eimeria vermiformis infection in immunosuppressed mice. Int. J. Parasit. 27: 329-337

  • Yun CH, Estrada, A, van Kessel, A, Gajadhar, A, Redmond, M and B Laarveld 1998. Immunomodulatory effects of oat β-glucan administered intragastrically or parenterally on mice infected with Eimeria vermiformis. Microbial Immunol. 42: 457-465