The effect of saffron (Crocus sativus L.) supplementation on blood pressure, and renal and liver function in patients with type 2 diabetes mellitus: A double-blinded, randomized clinical trial

Document Type : Original Research Article

Authors

1 Skull Base Research Center, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

2 Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran

3 Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

4 Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran

5 Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran

6 Department of Clinical Biochemistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran

7 Department of Clinical Biochemistry, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran

8 Department of Endocrinology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

Abstract

Objective: Microalbuminuria and hypertension are the risk factors for diabetic nephropathy, and increased levels of liver enzymes are prevalent among diabetic patients. The aim of this research was to examine the effects of Crocus sativus supplementation on nephropathy indices, liver enzymes, and blood pressure in patients with type 2 diabetes (T2D).
Materials and Methods: This placebo-controlled, randomized clinical trial was performed among 80 T2D patients. Subjects were randomly assigned to either Crocus sativus (n = 40) or placebo (n = 40) groups and treated with C. sativus and or placebo for 12 weeks, respectively. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum urea, creatinine, 24-hr urine albumin, systolic blood pressure (SBP), diastolic blood pressure (DBP), physical activity, and dietary intakes were measured and blood samples were taken at baseline and after the 12‑week intervention to assess the differences between the two groups.
Results: C. sativus supplementation compared with the placebo resulted in a significant reduction of SBP (P<0.005). However, changes in other indices including liver enzymes, serum creatinine, serum urea, and 24-hr urine albumin, and DBP were not significantly different between the two groups (p>0.05). Also, no significant changes in dietary intakes and physical activity were seen between the two groups.
Conclusion: This report shows that daily supplementation with 100 mg C. sativus powder improved SBP. However, it did not considerably improve DBP, nephropathy indices and liver functions in T2D patients after 12 weeks of administration. 

Keywords

Main Subjects

References

Ayatollahi H, Javan AO, Khajedaluee M, Shahroodian M, Hosseinzadeh H. 2014. Effect of Crocus sativus L. (saffron) on coagulation and anticoagulation systems in healthy volunteers. Phytother Res, 28: 539-543.
Azadmehr A, Ziaee A, Ghanei L, Huseini HF, Hajiaghaee R, Tavakoli-far B, Kordafshari G. 2014. A randomized clinical trial study: anti-oxidant, anti-hyperglycemic and anti-hyperlipidemic effects of olibanum gum in type 2 diabetic patients. Iran J Pharm Res, 13: 1003-1009.
Beckman JA, Creager MA, Libby P. 2002. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. Jama, 287:2570-2581.
Broadhead GK, Grigg JR, McCluskey P, Hong T, Schlub TE, Chang AA. 2019. Saffron therapy for the treatment of mild/moderate age-related macular degeneration: a randomised clinical trial. Graefes Arch Clin Exp Ophthalmol, 257: 31-40.
Caramori ML, Kim YH, Chunmei F, Alfred J, Rich SS, Miller ME, Mauer M. 2002. Cellular basis of diabetic nephropathy: 1. Study design and renal structural-functional relationships in patients with long-standing type 1 diabetes. Diabetes, 51: 506-513.
Darko D, Dornhorst A, Kelly FJ, Ritter JM, Chowienczyk PJ. 2002. Lack of effect of oral vitamin C on blood pressure, oxidative stress and endothelial function in Type II diabetes. Clin Sci, 103: 339-344.
De Vriese AS, Verbeuren TJ, Van de V, Johan L, Norbert H, Vanhoutte PM. 2000. Endothelial dysfunction in diabetes. Br J Pharmacol, 130: 963-974.
Elshater AE, Salman Muhammad MA, Moussa Mahrous MA. 2009. Effect of ginger extract consumption on levels of blood glucose, lipid profile and kidney functions in alloxan induced-diabetic rats. Egypt Acad J Biosci, 2: 153-162.
Esteghamati A, Gouya MM, Abbasi M, Delavari A, Alikhani S, Alaedini F, Gregg EW. 2008. Prevalence of diabetes and impaired fasting glucose in the adult population of Iran. Diabetes care, 31: 96-98.
Fatehi M, Rashidabady T, Fatehi-Hassanabad Z. 2003. Effects of Crocus sativus petals’ extract on rat blood pressure and on responses induced by electrical field stimulation in the rat isolated vas deferens and guinea-pig ileum. J Ethnopharmacol, 84: 199-203.
Ghaffarpour M, Houshiar-Rad A, Kianfar H. 1999. The manual for household measures, cooking yields factors and edible portion of foods. Tehran: Nashre Olume Keshavarzy, 7: 213.
Hanley AJG, Wagenknecht LE, Festa A, D'agostino RB, Haffner SM. 2007. Alanine aminotransferase and directly measured insulin sensitivity in a multiethnic cohort. Diabetes care, 30: 1819-1827.
Hofman DL, Van Buul VJ, Brouns Fred JPH. 2016. Nutrition, health, and regulatory aspects of digestible maltodextrins. Crit Rev Food Sci Nutr, 56: 2091-2100.
Huang HY, Chen YC, Wang PC, Tsai MA, Yeh SC, Liang HJ, Chen SC. 2014. Efficacy of a formalin-inactivated vaccine against Streptococcus iniae infection in the farmed grouper Epinephelus coioides by intraperitoneal immunization. Vaccine, 32, 7014-7020.
Imenshahidi M, Hosseinzadeh H, Javadpour Y. 2010. Hypotensive effect of aqueous saffron extract (Crocus sativus L.) and its constituents, safranal and crocin, in normotensive and hypertensive rats. Phytother Res, 24: 990-994.
Imenshahidi M, Razavi BM, Faal A, Gholampoor A, Mousavi SM, Hosseinzadeh H. 2014. Effects of chronic crocin treatment on desoxycorticosterone acetate (doca)-salt hypertensive rats. Iran J Basic Med Sci, 17: 9-13.
Jelodar G, Javid Z, Sahraian A, Jelodar S. 2018. Saffron improved depression and reduced homocysteine level in patients with major depression: A Randomized, double-blind study. Avicenna J Phytomed, 8: 43-50.
Jyothirmayi B, Kumar JS. 2011. Insulin resistance and alanine amino transaminase (ALT) levels in first degree relatives of type 2 diabetes mellitus. Diabetes & Metab-Res, 5: 143-147.
Kaur R, Khanna N. 2012. Pathophysiology and risk factors related to hypertension and its cure using herbal drugs. Spatula DD, 2: 245-256.
Larejani B, Zahedi F. 2001. Epidemiology of diabetes mellitus in Iran. IJDLD, 1: 1-8.
Lavie CJ, Osman AF, Milani RV, Mehra MR. 2003. Body composition and prognosis in chronic systolic heart failure: the obesity paradox. Am J Cardiol, 91: 891-894.
Li Y, Tran VH, Duke CC, Roufogalis BD. 2012. Gingerols of Zingiber officinale enhance glucose uptake by increasing cell surface GLUT4 in cultured L6 myotubes. Planta medica, 78: 1549-1555.
Mashmoul M, Azlan A, Mohtarrudin N, Yusof BNM, Khaza’ai H, Khoo HE, Boroushaki MT. 2016. Protective effects of saffron extract and crocin supplementation on fatty liver tissue of high-fat diet-induced obese rats. BMC Complement Altern Med, 16: 401-407.
Milajerdi A, Jazayeri S, Bitarafan V, Hashemzadeh N, Shirzadi E, Derakhshan Z, Akhondzadeh S. 2017. The effect of saffron (Crocus sativus L.) hydro-alcoholic extract on liver and renal functions in type 2 diabetic patients: A double-blinded randomized and placebo control trial. J Nutr Intermed Metab, 9: 6-11.
Mirfeizi M, Mehdizadeh TZ, Mirfeizi SZ, Asghari Jafarabadi M, Rezvani HR, Afzali M. 2016. Controlling type 2 diabetes mellitus with herbal medicines: A triple‐blind randomized clinical trial of efficacy and safety. J Diabetes, 8: 647-656.
Moazen-Zadeh E, Abbasi SH, Safi-Aghdam H, Shahmansouri N, Arjmandi-Beglar A, Hajhosseinn Talasaz A, Akhondzadeh S. 2018. Effects of saffron on cognition, anxiety, and depression in patients undergoing coronary artery bypass grafting: a randomized double-blind placebo-controlled trial. J Altern Complement Med, 24: 361-368.
Modaghegh MH, Shahabian M, Esmaeili HA, Rajbai O, Hosseinzadeh H. 2008. Safety evaluation of saffron (Crocus sativus) tablets in healthy volunteers. J Phymed, 15: 1032-1037.
Mohammadifard N, Sajjadi F, Maghroun M, Alikhasi H, Nilforoushzadeh F, Sarrafzadegan N. 2015. Validation of a simplified food frequency questionnaire for the assessment of dietary habits in Iranian adults: Isfahan Healthy Heart Program, Iran. ARYA atheroscler, 11: 139.
Moradabadi L, Kouhsari SM, Sani MF. 2013. Hypoglycemic effects of three medicinal plants in experimental diabetes: inhibition of rat intestinal α-glucosidase and enhanced pancreatic insulin and cardiac glut-4 mrnas expression. Iran J Pharm Res, 12: 387-397.
Naghizadeh B, Mansouri SM, Mashhadian NV. 2010. Crocin attenuates cisplatin-induced renal oxidative stress in rats. Food Chem Toxicol, 48: 2650-2655.
Omidi A, Riahinia N, Montazer Torbati MB. Behdani MA. 2014. Hepatoprotective effect of Crocus sativus (saffron) petals extract against acetaminophen toxicity in male Wistar rats. Avicenna J Phytomed, 4, 330-336.
Parving HH, Lehnert H, Bröchner-Mortensen J, Gomis R, Andersen S, Arner P. 2001. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med, 345: 870-878.
Pitsikas N, Boultadakis A, Georgiadou G, Tarantilis PA, Sakellaridis N. 2008. Effects of the active constituents of Crocus sativus L., crocins, in an animal model of anxiety. J Phymed, 15: 1135-1139.
Schulz KF, Altman DG, Moher D. 2010. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med, 8: 18.
Shanmugam KR, Ramakrishana Ch, Mallikarjuna K, Reddy KS. 2009. The impact of ginger on kidney carbohydrate metabolic profiles in STZ induced diabetic rats. Asian J Exp Sci, 23: 127-134.
Shemshian M, Mousavi SH, Norouzy A, Kermani T, Moghiman T, Sadeghi A, Ferns GA. 2014. Saffron in metabolic syndrome: its effects on antibody titers to heat-shock proteins 27, 60, 65 and 70. J Complement Integr Med, 11: 43-49.
Tajadadi-Ebrahimi M, Bahmani F, Shakeri H, Hadaegh H, Hijijafari M, Abedi F, Asemi Z. 2014. Effects of daily consumption of synbiotic bread on insulin metabolism and serum high-sensitivity C-reactive protein among diabetic patients: a double-blind, randomized, controlled clinical trial. Ann Nutr Metab, 65, 34-41.
Tavafi M, Ahmadvand H, Khalatbari A, Tamjidipoor A. 2011. Rosmarinic acid ameliorates diabetic nephropathy in uninephrectomized diabetic rats. IJBMS, 14: 275-283.
Vasheghani-Farahani A, Tahmasbi M, Asheri, Hossein A, Haleh Nedjat S, Kordi R. 2011. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med, 2: 106-116.
Whiting DR, Guariguata L, Weil C, Shaw J. 2011. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract, 94: 311-321.
Xi L, Qian Z, Xu G, Zheng S, Sun S, Wen N, Zhang Y 2007. Beneficial impact of crocetin, a carotenoid from saffron, on insulin sensitivity in fructose-fed rats.  J Nutr Biochem, 18: 64-72.
Xiang M, Qian ZY, Zhou CH, Liu J, Li WN. 2006. Crocetin inhibits leukocyte adherence to vascular endothelial cells induced by AGEs. J Ethnopharmacol, 107: 25-31.
Zheng S, Qian Z, Tang F, Sheng L. 2005. Suppression of vascular cell adhesion molecule-1 expression by crocetin contributes to attenuation of atherosclerosis in hypercholesterolemic rabbits. Biochem Pharmacol, 70: 1192-1199.
 
Avicenna Journal of Phytomedicine
Volume 9, Issue 4
July and August 2019
Pages 322-333

Files

Share

How to cite

Statistics