A Randomized Clinical Trial Study Protocol on the Effect of Barley Savigh on Blood Glucose in Prediabetic Menopausal Women

Document Type : Research Paper

Authors

1 MSc student of Midwifery, Department of Midwifery, Faculty of Medicine, Gonabad University of Medical Sciences, Gonabad, Iran.

2 Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Department of Nutrition, Varastegan Institute for Medical Sciences, Mashhad, Iran.

4 MSc of Biostatistics, Department of Epidemiology and Biostatistics, School of Health, Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.

5 Associate professor of Reproductive Health, Department of Midwifery, Faculty of Medicine, Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.

Abstract

Introduction: Hormonal changes during menopause may result in type 2 diabetes. Therefore, the prevention of diabetes and its complications is essential during menopause. The effects of barley (Hordeum vulgare L) in maintaining blood glucose and insulin have been previously reported. This study was designed to evaluate the impact of roasted barley flour consumption on the blood sugar level of prediabetic postmenopausal women. Methods: This randomized controlled trial study will be conducted on 68 prediabetic postmenopausal women referring to community health centers in Gonabad, Iran. All participants will complete a demographic questionnaire, and their fasting and two-hour postprandial blood glucose levels, HbA1C, will be recorded. The intervention group will receive 60g of roasted barley flour daily (20g before each meal) for four weeks, while the control group will receive no intervention. Fasting and two-hour postprandial blood glucose will be checked by venous blood sampling at baseline, two and four weeks after intervention. All participants will complete three-day food intake record and Beck's physical activity questionnaire during the study. Data will be analyzed using the statistical package for social sciences (SPSS) software (version 16), and a p-value less than 0.05 will be considered significant. Conclusion: This study may prove the effectiveness of roasted barley flour in reducing blood glucose. Daily consumption of this compound can be recommended for prediabetic menopausal women.

Keywords


  1. Sayahi M, Zakerkish M, Haghighizadeh M H, ziagham S. Relationship between menopausal symptoms, age, body mass index and metabolic syndrome in postmenopausal women in a number of health centers in Ahvaz in 2013. J Arak Uni Med Sci. 2015; 17 (10):50-7
  2. Mehdizadeh R. The effect of core stability training on body composition and lipoprotein in menopausal older women. Salmand. Iranian Journal of Ageing. 2015; 10(2):153-63
  3. Shabani R. The Effect of Concurrent Aerobic–Resistance Exercise Training on Estrogen Level and Glucose Homeostasis of Menopausal Females with Blood Glucose Impairment. Iranian Journal of Rehabilitation Research. 2017:3(3):1-10.
  4. Slopien R, Wender-Ozegowska E, Rogowicz-Frontczak A, Meczekalski B, Zozulinska-Ziolkiewicz D, Jaremek JD, et al. Menopause and diabetes: EMAS clinical guide. Maturitas. 2018; 117:6-10
  5. Ziaei S, Ziagham S, Sayahi M. Relationship between menopausal age and metabolic syndrome in non-obese postmenopausal women. J Arak Uni Med Sci. 2013; 16(5):41-8.
  6. Bakhtiari MR. a review on the latest criteria for laboratory diagnosis of diabetes mellitus, pre-diabetes and gestational diabetes. Journal of laboratory and diagnosis. 2014; 6(24):4-8.
  7. Yazdani A, M, Marjan, F, Elham, Zareh M, A, Masoud. The effects of macronutrient intake on the risk of pre-diabetes in first degree relatives of patients with type 2 diabetes. Journal of Isfahan Medical School. 2014; 32:301.
  8. Bathaie S, Mokarizade N, Shirali S. An overview of the mechanisms of plant ingredients in the treatment of diabetes mellitus. J Med Plants. 2012; 11 (44):1-24.
  9. Tosh SM. Review of human studies investigating the post-prandial blood-glucose lowering ability of oat and barley food products. European Journal of Clinical Nutrition. 2013; 67(4):310.
  10. Arbai F, Minae zangi B, Sadooghi M. The effect of hordeum vulgare L. on the development of lung tissues in the embryo of diabetic albino rats. Comparative Pathobiology, Science-Research. 2014; 11(4(47)):1429-36
  11. Mohsenzadeh A, Javadi T, Yari F, Shah K. Effect of barley flour on neonatal jaundice reduction. Yafte. 2013; 2(3):17-22.
  12. Nazari H, Jahanjo N, Safarieh M, Taherian M, Khaleghian A, Vafaei A. The effect of avena sativa alcoholic and aqueous extract on the wound healing and skin inflammation. J Urmia Univ Med Sci. 2011; 22(5):467-73.
  13. Kamrani Moghadam L, Sadoughi, Zangi M, Farmani M, Ramazani, Najd F. The effects of barley grain (Hordeum Vulgare L.) during pregnancy on development and heart histopathological changes of embryos of diabetic rats. Razi Journal of Medical Sciences. 2015; 22(133):80-8.
  14. Goto Y, Nishimoto Y, Murakami S, Nomaguchi T, Mori Y, Ito M, Nakaguro R, Kudo T, Matsuoka T, Yamada T, Kobayashi T, Fukuda S. Metabologenomic approach reveals intestinal environmental features associated with barley-induced glucose tolerance improvements in Japanese: A Randomized Controlled Trial. Nutrients. 2022; 14(17):3468.
  15. Mokhtari F, Esfarjani F, Kargar Fard M. The effect of combined aerobic exercise and barley B-glucan on lipid profile and glucose blood of women with diabetes type two .Journal of Diabetes and Metabolism of Iran. 2014; 13(4):340-51.
  16. Najjar safari S, Rezvani SV, Haji Faraji M, Rashidkhani B. The effect of "real oat bread" compared with "barley bread offered in Tehran" on serum glucose and lipid profiles in dyslipidemia and type 2 diabetic subjects. Iranian Journal of Endocrinology and Metabolism. 2011; 13(3):233-42.
  17. Montazeri Far F, Karaji Bani M, Ali Kikhuaei M, Dashipour A, Amiyar M, Nikoei G. Effect of breads in Iran on blood glucose level in patients with type 2 diabetes. Yafteh. 2016; 18(2):67-75.
  18. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Available at: https://www.spirit-statement.org/. [Site access: 25 Dec 2022].
  19. Mokhtari F, Esfarjani F, Kargar Fard M. The effect of combined aerobic exercise and barley B-glucan on lipid profile and glucose blood of women with diabetes type two .Journal of Diabetes and Metabolism of Iran. 2014; 13(4):340-51.
  20. Sarvghadi F, Yasari F, Yavari P. Causes and clinical presentations of hypoglycemia in patients with low blood glucose admitted to the emergency ward. Iranian Journal of Endocrinology and Metabolism. 2006; 8(1):57-62.
  21. Tosh SM, Bordenave N. Emerging science on benefits of whole grain oat and barley and their soluble dietary fibers for heart health, glycemic response, and gut microbiota. Nutr Rev. 2020; 78(Suppl 1):13-20.