The effects of green cardamom supplementation on blood glucose, lipids profile, oxidative stress, sirtuin-1 and irisin in type 2 diabetic patients: a study protocol for a randomized placebo-controlled clinical trial

Mohadeseh Aghasi, Shohreh Ghazi-Zahedi, Fariba Koohdani, Fereydoun Siassi, Ensieh Nasli-Esfahani, Ali Keshavarz, Mostafa Qorbani, Hoorieh Khoshamal, Asma Salari-Moghaddam, Gity Sotoudeh, Mohadeseh Aghasi, Shohreh Ghazi-Zahedi, Fariba Koohdani, Fereydoun Siassi, Ensieh Nasli-Esfahani, Ali Keshavarz, Mostafa Qorbani, Hoorieh Khoshamal, Asma Salari-Moghaddam, Gity Sotoudeh

Abstract

Background: It has been suggested that the antioxidant, anti-inflammatory and hypolipidemic activities of cardamom may improve diabetes. However, the effect of this spice has not been investigated in diabetic subjects. This study was planned to determine the effects of green cardamom on blood glucose, lipids and oxidative stress status in type 2 diabetic patients.

Methods/design: Eighty overweight or obese patients with type 2 diabetes will be selected. They will be randomly assigned to receive 3 g/d green cardamom or placebo for 10 weeks. The socio demographic, physical activity and 24-h food recall questionnaires will be collected for each subject. Weight, height and waist circumference will be measured. Determination of blood glucose, lipid profile, and oxidative stress biomarkers including serum levels of total antioxidant capacity (TAC), malondialdehyde (MDA), and glutathione peroxidase (GPx) and superoxide dismutase (SOD) in red blood cells will be performed. The homeostasis model assessment-estimated insulin resistance (HOMA-IR) index and the quantitative insulin-sensitivity check index (QUICKI) will be calculated. Also, serum levels of irisin, and Sirtuin1 (SIRT1) will be measured.

Discussion: This trial will be the first study to explore the effects of green cardamom supplementation on glycemic control, lipid profile and oxidative stress in patients with type 2 diabetes mellitus. The results from this trial will provide evidence on the efficacy of green cardamom in type 2 diabetes mellitus.

Trial registration number: ( http://www.irct.ir , identifier: IRCT2016042717254N5), Registration date: 23.11.2016.

Keywords: Diabetes; Green cardamom; Trial protocol.

Conflict of interest statement

Ethics approval and consent to participate

The Ethics Committee of Tehran University of Medical Sciences has approved study protocol (IR.TUMS.REC.1395.2700). A written informed consent form will be signed and dated by subjects and investigators at the beginning of the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participants flow diagram

References

    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5),1047–1053.[Pubmed].
    1. Ejtahed HS, Mohtadi-Nia J, Homayouni-Rad A, Niafar M, Asghari-Jafarabadi M, Mofid V, et al. Effect of probiotic yogurt containing Lactobacillus acidophilus and Bifidobacterium lactis on lipid profile in individuals with type 2 diabetes mellitus. J Dairy Sci. 2011;94(7),3288–3294.[Pubmed].
    1. Sakuraba H, Mizukami H, Yagihashi N, Wada R, Hanyu C, Yagihashi S. Reduced beta-cell mass and expression of oxidative stress-related DNA damage in the islet of Japanese Type II diabetic patients. Diabetologia. 2002;45(1), 85–96.[Pubmed].
    1. Mohamed AK, Bierhaus A, Schiekofer S, Tritschler H, Ziegler R, Nawroth PP. The role of oxidative stress and NF-kappaB activation in late diabetic complications. BioFactors. 1999;10(2–3),157–167.[Pubmed].
    1. Karunakaran U, Park KG. A systematic review of oxidative stress and safety of antioxidants in diabetes: Focus on islets and their defense. Diabetes Metab J. 2013;37(2),106–112.[Pubmed].
    1. Chung S, Yao H, Hwang JW, Arunachalam G, Rahman I. Regulation of SIRT1 in cellular functions: role of polyphenols. Arch Bioche Biophys. 2010;1;501(1),79–90.[Pubmed].
    1. Kitada M. and Koya D. SIRT1 in Type 2 Diabetes: Mechanisms and Therapeutic Potential. Diabetes Metab J. 2013; 37(5), 315.[Pubmed].
    1. Cao Y, Jiang X, Ma H, Wang Y, Xue P, and Liu Y. SIRT1 and insulin resistance. J. Diabetes Complications. 2016;30(1),178–183.[Pubmed].
    1. Mahmoodnia L, Sadoughi M, Ahmadi A, and Kafeshani M. Relationship between serum irisin, glycemic indices, and renal function in type 2 diabetic patients. J Renal Inj Prev. 2016; 6(2), 88–92.[Pubmed].
    1. Shanaki M, Moradi N, Emamgholipour S, Fadaei R and Poustchi H. Lower circulating irisin is associated with nonalcoholic fatty liver disease and type 2 diabetes. Diabetes Metab. Syndr. 2017;11:S467-S472.[Pubmed].
    1. Davis JM, Murphy EA & Carmichael MD. Effects of the dietary flavonoid quercetin upon performance and health. Curr Sports Med Rep. 2013;8(4):206–213.[Pubmed].
    1. Joseph AM and Hood DA. Relationships between Exercise, Mitochondrial Biogenesis and Type 2 Diabetes. Med Sport Sci. 2014;60, 48–61.[Pubmed].
    1. Ağaoğlu, S, Dostbil N & Alemdar S. Antimicrobial Effect of Seed Extract of Cardamom (Elettarıa cardamomum Maton). YÜ Vet Fak Derg. 2006;16(2),99–101.view article.
    1. Suneetha WJ & Krishnakantha TP. Cardamom extract as inhibitor of human platelet aggregation. Phytother Res. 2005;19(5),437–440.[Pubmed].
    1. Ahmed AS, Ahmed Q, Saxena AK, and Jamal P. Evaluation of in vitro antidiabetic and antioxidant characterizations of Elettaria cardamomum (L.) Maton (Zingiberaceae), Piper cubeba L. f. (Piperaceae), and Plumeria rubra L. (Apocynaceae). Pak. J. Pharm. Sci. 2017; 30(1) ,113–126.[pubmed].
    1. Bhattacharjee B, Chatterjee J. Identification of proapoptopic, anti-inflammatory, anti- proliferative, anti-invasive and anti-angiogenic targets of essential oils in cardamom by dual reverse virtual screening and binding pose analysis. Asian Pac J Cancer Prev. 2013;14(6),3735–3742.[Pubmed].
    1. Jin S, Cho KH. Water extracts of cinnamon and clove exhibits potent inhibition of protein glycation and anti-atherosclerotic activity in vitro and in vivo hypolipidemic activity in zebrafish. Food Chem Toxical. 2011;49(7),1521–1529.[Pubmed].
    1. Cho KH. 1,8-Cineole Protected Human Lipoproteins From Modification By Oxidation and Glycation and Exhibited Serum Lipid-Lowering and Anti-Inflammatory Activity in Zebrafish. BMB Rep. 2012;45(10),565–570.[Pubmed].
    1. Deepa G, Ayesha S, Nishtha K, Thankamani M. Comparative evaluation of various total antioxidant capacity assays applied to phytochemical compounds of indian culinary spices. Int food res J. 2013;20(4), 1711–1716. View article.
    1. De boer VCJ, de Goffau MC, Arts ICW, Hollman PCH, Keijer J. SIRT1 stimulation by polyphenols is affected by their stability and metabolism. Mech Ageing Dev. 2006;127(7),618–627.[Pubmed].
    1. Kandikattu H. K., Rachitha P, Jayashree GV, Krupashree K, Sukhith M, Majid A, Amruta N, Khanum F. Anti-inflammatory and anti-oxidant effects of Cardamom (Elettaria repens (Sonn.) Baill) and its phytochemical analysis by 4D GCXGC TOF-MS. Biomed Pharmacother. 2017;91, 191–201.[Pubmed].
    1. Azimi P, Ghiasvand R, Feizi A, Hariri M, and Abbasi B. Effects of cinnamon, cardamom, saffron and ginger consumption on markers on glycemic control, lipid profile, oxidative stress and Inflammation in type 2 diabetes patients. Rev Diabet Stud. 2014; 11(3), 258–266.[Pubmed].
    1. kazemi S, Yaghooblou F, Siassi F, Rahimi A, Ghavipour M, Koohdani F, Sotoudeh G. Cardamom supplementation improves inflammatory and oxidative stress biomarkers in hyperlipidemic, overweight, and obese pre-diabetic women: A randomized double-blind clinical trial. J. Sci. Food Agric. 2017;97(15):5296-5301.[Pubmed].
    1. Verma SK, Jain V & Singh DP. Effect of Greater cardamom (Amomum subulatum Roxb.) on blood lipids, fibrinolysis and total antioxidant status in patients with ischemic heart disease. Asian Pac J Trop Dis. 2012;S739–S743.[Science Direct].
    1. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2012;35(Suppl 1):S64–S71. [Pubmed].
    1. Evdokimova OV, Tarrab I, Neneleva EV, Glazkova IY. Testing phenol compounds in spices. European Journal of Applied Sciences. 2013;5(5):142–145.
    1. M C, Kaefer & Milner J A. Herbs and Spices in Cancer Prevention and Treatment. Herbal Medicine: Biomolecular and Clinical Aspects. 2011;19(6),347–361.[Pubmed].
    1. Miller NJ, Rice-Evans C, Davies MJ, Gopinathan V, Milner A. A novel method for measuring antioxidant capacity and its application to monitoring the antioxidant status in premature neonates. Clin Sci (Lond). 1993;84(4),407–412.[Pubmed].
    1. Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8),1381–1395.[Pubmed].
    1. Chen J, Huang Y, Gusdon A M and Qu S. Irisin: a new molecular marker and target in metabolic disorder. Lipids Health Dis. 2015;14, 2.[Pubmed].
    1. Amma KPAP, Rani MP, Sasidharan I, Nisha VNP. Chemical composition, flavonoid - phenolic contents and radical scavenging activity of four major varieties of cardamom. Int J Biol Med Res. 2010;1(3),20–24.View Article.
    1. Souri E, Amin G, Farsam H, M BT. Screening of antioxidant activity and phenolic content of 24 medicinal plant extracts. DARU. 2008;16(2), 83–87. View Article.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera