Effect of Nigella sativa Supplementation on Lipid Profile in Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Abstract
Objectives: Type 2 diabetes has become a global health burden, especially in developing nations, and is frequently linked to dyslipidemia. While various medications are available, there is a growing interest in herbal remedies such as Nigella sativa (N. sativa) as alternative treatments for type 2 diabetes. In this systematic review and meta-analysis, the objective was to assess the impact of N. sativa on the lipid profile of patients with type 2 diabetes.
Methods: Online databases, including Web of Science, Scopus, PubMed, and EMBASE, were searched. Changes in lipid profile parameters were reported as weighted mean differences, along with a 95% confidence interval. Sensitivity analysis, quality assessment, subgroup analysis, and publication bias were evaluated in the eligible studies.
Results: The study was performed on eight randomized controlled trials (RCTs) involving 1030 participants. According to the findings, supplementation of N. sativa in the form of seed powder or oil significantly reduced total cholesterol and LDL-cholesterol levels, while increasing HDL-cholesterol levels in patients with type 2 diabetes. The funnel plot exhibited visual symmetry for the studies included in the meta-analysis.
Conclusion: The findings indicate that N sativa may be beneficial as an adjunctive treatment alongside standard medications for managing dyslipidemia in individuals with type 2 diabetes.
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7. Ghahremani, H., A. Bahramzadeh, K. Bolandnazar, S. Emamgholipor, H. Hosseini, and R. Meshkani, Resveratrol as a potential protective compound against metabolic inflammation. Acta Biochimica Iranica, 2023. 1(2): p. 50-64.
8. Bahramzadeh, A., K. Bolandnazar, and R. Meshkani, Resveratrol as a potential protective compound against skeletal muscle insulin resistance. Heliyon, 2023.
9. Warraich, H.J. and J.S. Rana, Dyslipidemia in diabetes mellitus and cardiovascular disease. Cardiovascular Endocrinology, 2017. 6(1): p. 27.
10. Chehade, J.M., M. Gladysz, and A.D. Mooradian, Dyslipidemia in type 2 diabetes: prevalence, pathophysiology, and management. Drugs, 2013. 73: p. 327-339.
11. Mooradian, A.D., Dyslipidemia in type 2 diabetes mellitus. Nature Reviews Endocrinology, 2009. 5(3): p. 150-159.
12. Khorzoughi, R.B. and R. Meshkani, Beneficial Effect of Metformin, Quercetin, and Resveratrol Combination on High Glucose-Induced lipogenesis in HepG2 Cells. Acta Biochimica Iranica, 2023. 1(2): p. 96-104.
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17. Otoom, S., S. Al-Safi, Z. Kerem, and A. Alkofahi, The use of medicinal herbs by diabetic Jordanian patients. Journal of herbal pharmacotherapy, 2006. 6(2): p. 31-41.
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21. Fadaei R, Adipokines as a link between adipose tissue with inflammation and insulin resistance in cardiometabolic diseases. Acta Biochimica Iranica, 2023. 1(3): p. 112-118.
22. Bakathir, H.A. and N.A. Abbas, Detection of the antibacterial effect of nigella sativa ground seedswith water. African Journal of Traditional, Complementary and Alternative Medicines, 2011. 8(2).
23. Shafiee-Nick, R., A. Ghorbani, F. Vafaee Bagheri, and H. Rakhshandeh, Chronic administration of a combination of six herbs inhibits the progression of hyperglycemia and decreases serum lipids and aspartate amino transferase activity in diabetic rats. Advances in pharmacological sciences, 2012. 2012.
24. Gilani, A.-u.H., Q. Jabeen, and M.A.U. Khan, A review of medicinal uses and pharmacological activities of Nigella sativa. Pak J Biol Sci, 2004. 7(4): p. 441-51.
25. Abdul-Rahman, N.Z. and N.S. Mohd-Zubri, Therapeutic potential of Nigella sativa, in Biochemistry, Nutrition, and Therapeutics of Black Cumin Seed. 2023, Elsevier. p. 127-142.
26. Ahmad, A., A. Husain, M. Mujeeb, S.A. Khan, A.K. Najmi, N.A. Siddique, et al., A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pacific journal of tropical biomedicine, 2013. 3(5): p. 337-352.
27. Tembhurne, S., S. Feroz, B. More, and D. Sakarkar, A review on therapeutic potential of Nigella sativa (kalonji) seeds. J Med Plants Res, 2014. 8(3): p. 167-177.
28. Cheikh-Rouhou, S., S. Besbes, B. Hentati, C. Blecker, C. Deroanne, and H. Attia, Nigella sativa L.: Chemical composition and physicochemical characteristics of lipid fraction. Food chemistry, 2007. 101(2): p. 673-681.
29. Nergiz, C. and S. Ötleş, Chemical composition of Nigella sativa L. seeds. Food chemistry, 1993. 48(3): p. 259-261.
30. Meral, I., Z. Yener, T. Kahraman, and N. Mert, Effect of Nigella sativa on glucose concentration, lipid peroxidation, anti‐oxidant defence system and liver damage in experimentally‐induced diabetic rabbits. Journal of veterinary medicine series A, 2001. 48(10): p. 593-599.
31. Al-Naqeep, G., M. Ismail, and Z. Allaudin, Regulation of low-density lipoprotein receptor and 3-hydroxy-3-methylglutaryl coenzyme A reductase gene expression by thymoquinone-rich fraction and thymoquinone in HepG2 cells. Lifestyle Genomics, 2009. 2(4-5): p. 163-172.
32. Ahmad, S. and Z.H. Beg, Elucidation of mechanisms of actions of thymoquinone-enriched methanolic and volatile oil extracts from Nigella sativa against cardiovascular risk parameters in experimental hyperlipidemia. Lipids in health and disease, 2013. 12(1): p. 1-12.
33. Najmi, A., S. Haque, M. Naseeruddin, and R. Khan, Effect of Nigella sativa oil on various clinical and biochemical parameters of metabolic syndrome. Int J Diabetes Dev Ctries, 2008. 16: p. 85-87.
34. Bhatti, I.U., F.U. Rehman, M.A. Khan, and S.K. Marwat, Effect of prophetic medicine Kalonji (Nigella sativa L.) on lipid profile of human beings: an in vivo approach. World Applied Sciences Journal, 2009. 6(8): p. 1053-1057.
35. Bamosa, A.O., H. Kaatabi, F.M. Lebdaa, A. Elq, and A. Al-Sultanb, Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus. Indian J Physiol Pharmacol, 2010. 54(4): p. 344-54.
36. Ahmad, S. and Z.H. Beg, Hypolipidemic and antioxidant activities of thymoquinone and limonene in atherogenic suspension fed rats. Food chemistry, 2013. 138(2-3): p. 1116-1124.
37. Hamed Ahmad Alobaidi, A., Effect of Nigella Sativa and Allium Sativum Coadminstered with Simvastatin in Dyslipidemia Patients: A Prospective, Randomized, Double-Blind Trial. Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry (Formerly Current Medicinal Chemistry-Anti-Inflammatory and Anti-Allergy Agents), 2014. 13(1): p. 68-74.
38. Amin, F., N. Islam, N. Anila, and A. Gilani, Clinical efficacy of the co-administration of Turmeric and Black seeds (Kalongi) in metabolic syndrome–A double blind randomized controlled trial–TAK-MetS trial. Complementary therapies in medicine, 2015. 23(2): p. 165-174.
39. Moher, D., A. Liberati, J. Tetzlaff, D.G. Altman, and P. Group*, Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Annals of internal medicine, 2009. 151(4): p. 264-269.
40. Hosseini, H., M. Koushki, H. Khodabandehloo, M. Fathi, G. Panahi, M. Teimouri, et al., The effect of resveratrol supplementation on C-reactive protein (CRP) in type 2 diabetic patients: Results from a systematic review and meta-analysis of randomized controlled trials. Complementary therapies in medicine, 2020. 49: p. 102251.
41. Higgins, J.P., D.G. Altman, P.C. Gøtzsche, P. Jüni, D. Moher, A.D. Oxman, et al., The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj, 2011. 343.
42. Borenstein, M., L. Hedges, J. Higgins, and H. Rothstein, Comprehensive meta-analysis version 3 [software] Biostat. Englewood, NJ, 2013.
43. Higgins, J.P., S.G. Thompson, J.J. Deeks, and D.G. Altman, Measuring inconsistency in meta-analyses. Bmj, 2003. 327(7414): p. 557-560.
44. DerSimonian, R. and N. Laird, Meta-analysis in clinical trials. Controlled clinical trials, 1986. 7(3): p. 177-188.
45. Begg, C.B. and J.A. Berlin, Publication bias and dissemination of clinical research. JNCI: Journal of the National Cancer Institute, 1989. 81(2): p. 107-115.
46. Egger, M., G.D. Smith, M. Schneider, and C. Minder, Bias in meta-analysis detected by a simple, graphical test. Bmj, 1997. 315(7109): p. 629-634.
47. Badar, A., H. Kaatabi, A. Bamosa, A. Al-Elq, B. Abou-Hozaifa, F. Lebda, et al., Effect of Nigella sativa supplementation over a one-year period on lipid levels, blood pressure and heart rate in type-2 diabetic patients receiving oral hypoglycemic agents: nonrandomized clinical trial. Annals of Saudi medicine, 2017. 37(1): p. 56-63.
48. Kaatabi, H., A.O. Bamosa, A. Badar, A. Al-Elq, B. Abou-Hozaifa, F. Lebda, et al., Nigella sativa improves glycemic control and ameliorates oxidative stress in patients with type 2 diabetes mellitus: placebo controlled participant blinded clinical trial. PloS one, 2015. 10(2): p. e0113486.
49. Najmi, A., M. Nasiruddin, R. Khan, and S.F. Haque, Therapeutic effect of Nigella sativa in patients of poor glycemic control. Asian J Pharm Clin Res, 2012. 5(3): p. 224-8.
50. Moustafa, H.A.M., L.M. El Wakeel, M.R. Halawa, N.A. Sabri, A.Z. El-Bahy, and A.N. Singab, Effect of Nigella Sativa oil versus metformin on glycemic control and biochemical parameters of newly diagnosed type 2 diabetes mellitus patients. Endocrine, 2019. 65(2): p. 286-294.
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2. Teimouri, M., H. Hosseini, M. Shabani, M. Koushki, F. Noorbakhsh, and R. Meshkani, Inhibiting miR‐27a and miR‐142‐5p attenuate nonalcoholic fatty liver disease by regulating Nrf2 signaling pathway. IUBMB life, 2020. 72(3): p. 361-372.
3. Pinti, M.V., G.K. Fink, Q.A. Hathaway, A.J. Durr, A. Kunovac, and J.M. Hollander, Mitochondrial dysfunction in type 2 diabetes mellitus: an organ-based analysis. American Journal of Physiology-Endocrinology and Metabolism, 2019. 316(2): p. E268-E285.
4. Lotfy, M., J. Adeghate, H. Kalasz, J. Singh, and E. Adeghate, Chronic complications of diabetes mellitus: a mini review. Current diabetes reviews, 2017. 13(1): p. 3-10.
5. Khodabandehloo, H., S. Gorgani-Firuzjaee, G. Panahi, and R. Meshkani, Molecular and cellular mechanisms linking inflammation to insulin resistance and β-cell dysfunction. Translational Research, 2016. 167(1): p. 228-256.
6. Chahkandi, S., R. Dabiri, M. Mirmohammadkhani, N. Amiri-Dashatan, and M. Koushki, The effect of silymarin on liver enzymes and serum lipid profiles in Iranian patients with non-alcoholic fatty liver disease: A double-blind randomized controlled trial. Acta Biochimica Iranica, 2023.
7. Ghahremani, H., A. Bahramzadeh, K. Bolandnazar, S. Emamgholipor, H. Hosseini, and R. Meshkani, Resveratrol as a potential protective compound against metabolic inflammation. Acta Biochimica Iranica, 2023. 1(2): p. 50-64.
8. Bahramzadeh, A., K. Bolandnazar, and R. Meshkani, Resveratrol as a potential protective compound against skeletal muscle insulin resistance. Heliyon, 2023.
9. Warraich, H.J. and J.S. Rana, Dyslipidemia in diabetes mellitus and cardiovascular disease. Cardiovascular Endocrinology, 2017. 6(1): p. 27.
10. Chehade, J.M., M. Gladysz, and A.D. Mooradian, Dyslipidemia in type 2 diabetes: prevalence, pathophysiology, and management. Drugs, 2013. 73: p. 327-339.
11. Mooradian, A.D., Dyslipidemia in type 2 diabetes mellitus. Nature Reviews Endocrinology, 2009. 5(3): p. 150-159.
12. Khorzoughi, R.B. and R. Meshkani, Beneficial Effect of Metformin, Quercetin, and Resveratrol Combination on High Glucose-Induced lipogenesis in HepG2 Cells. Acta Biochimica Iranica, 2023. 1(2): p. 96-104.
13. Pakkir Maideen, N.M., G. Manavalan, and K. Balasubramanian, Drug interactions of meglitinide antidiabetics involving CYP enzymes and OATP1B1 transporter. Therapeutic advances in endocrinology and metabolism, 2018. 9(8): p. 259-268.
14. Maideen, N.M.P. and R. Balasubramaniam, Pharmacologically relevant drug interactions of sulfonylurea antidiabetics with common herbs. Journal of Herbmed Pharmacology, 2018. 7(3).
15. Baumann, B.C., K.M. MacArthur, and J.C. Baumann, Emotional support animals on commercial flights: a risk to allergic patients. The Lancet Respiratory Medicine, 2016. 4(7): p. 544-545.
16. Ekor, M., The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Frontiers in pharmacology, 2014. 4: p. 177.
17. Otoom, S., S. Al-Safi, Z. Kerem, and A. Alkofahi, The use of medicinal herbs by diabetic Jordanian patients. Journal of herbal pharmacotherapy, 2006. 6(2): p. 31-41.
18. Suksomboon, N., N. Poolsup, S. Boonkaew, and C.C. Suthisisang, Meta-analysis of the effect of herbal supplement on glycemic control in type 2 diabetes. Journal of Ethnopharmacology, 2011. 137(3): p. 1328-1333.
19. Demmers, A., H. Korthout, F. van Etten-Jamaludin, F. Kortekaas, and J. Maaskant, Effects of medicinal food plants on impaired glucose tolerance: A systematic review of randomized controlled trials. diabetes research and clinical practice, 2017. 131: p. 91-106.
20. Gorgani-Firuzjaee, S. and R. Meshkani, Resveratrol reduces high glucose-induced de-novo lipogenesis through mTOR mediated induction of autophagy in HepG2 cells. Acta Biochimica Iranica, 2023. 1(1): p. 32-39.
21. Fadaei R, Adipokines as a link between adipose tissue with inflammation and insulin resistance in cardiometabolic diseases. Acta Biochimica Iranica, 2023. 1(3): p. 112-118.
22. Bakathir, H.A. and N.A. Abbas, Detection of the antibacterial effect of nigella sativa ground seedswith water. African Journal of Traditional, Complementary and Alternative Medicines, 2011. 8(2).
23. Shafiee-Nick, R., A. Ghorbani, F. Vafaee Bagheri, and H. Rakhshandeh, Chronic administration of a combination of six herbs inhibits the progression of hyperglycemia and decreases serum lipids and aspartate amino transferase activity in diabetic rats. Advances in pharmacological sciences, 2012. 2012.
24. Gilani, A.-u.H., Q. Jabeen, and M.A.U. Khan, A review of medicinal uses and pharmacological activities of Nigella sativa. Pak J Biol Sci, 2004. 7(4): p. 441-51.
25. Abdul-Rahman, N.Z. and N.S. Mohd-Zubri, Therapeutic potential of Nigella sativa, in Biochemistry, Nutrition, and Therapeutics of Black Cumin Seed. 2023, Elsevier. p. 127-142.
26. Ahmad, A., A. Husain, M. Mujeeb, S.A. Khan, A.K. Najmi, N.A. Siddique, et al., A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pacific journal of tropical biomedicine, 2013. 3(5): p. 337-352.
27. Tembhurne, S., S. Feroz, B. More, and D. Sakarkar, A review on therapeutic potential of Nigella sativa (kalonji) seeds. J Med Plants Res, 2014. 8(3): p. 167-177.
28. Cheikh-Rouhou, S., S. Besbes, B. Hentati, C. Blecker, C. Deroanne, and H. Attia, Nigella sativa L.: Chemical composition and physicochemical characteristics of lipid fraction. Food chemistry, 2007. 101(2): p. 673-681.
29. Nergiz, C. and S. Ötleş, Chemical composition of Nigella sativa L. seeds. Food chemistry, 1993. 48(3): p. 259-261.
30. Meral, I., Z. Yener, T. Kahraman, and N. Mert, Effect of Nigella sativa on glucose concentration, lipid peroxidation, anti‐oxidant defence system and liver damage in experimentally‐induced diabetic rabbits. Journal of veterinary medicine series A, 2001. 48(10): p. 593-599.
31. Al-Naqeep, G., M. Ismail, and Z. Allaudin, Regulation of low-density lipoprotein receptor and 3-hydroxy-3-methylglutaryl coenzyme A reductase gene expression by thymoquinone-rich fraction and thymoquinone in HepG2 cells. Lifestyle Genomics, 2009. 2(4-5): p. 163-172.
32. Ahmad, S. and Z.H. Beg, Elucidation of mechanisms of actions of thymoquinone-enriched methanolic and volatile oil extracts from Nigella sativa against cardiovascular risk parameters in experimental hyperlipidemia. Lipids in health and disease, 2013. 12(1): p. 1-12.
33. Najmi, A., S. Haque, M. Naseeruddin, and R. Khan, Effect of Nigella sativa oil on various clinical and biochemical parameters of metabolic syndrome. Int J Diabetes Dev Ctries, 2008. 16: p. 85-87.
34. Bhatti, I.U., F.U. Rehman, M.A. Khan, and S.K. Marwat, Effect of prophetic medicine Kalonji (Nigella sativa L.) on lipid profile of human beings: an in vivo approach. World Applied Sciences Journal, 2009. 6(8): p. 1053-1057.
35. Bamosa, A.O., H. Kaatabi, F.M. Lebdaa, A. Elq, and A. Al-Sultanb, Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus. Indian J Physiol Pharmacol, 2010. 54(4): p. 344-54.
36. Ahmad, S. and Z.H. Beg, Hypolipidemic and antioxidant activities of thymoquinone and limonene in atherogenic suspension fed rats. Food chemistry, 2013. 138(2-3): p. 1116-1124.
37. Hamed Ahmad Alobaidi, A., Effect of Nigella Sativa and Allium Sativum Coadminstered with Simvastatin in Dyslipidemia Patients: A Prospective, Randomized, Double-Blind Trial. Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry (Formerly Current Medicinal Chemistry-Anti-Inflammatory and Anti-Allergy Agents), 2014. 13(1): p. 68-74.
38. Amin, F., N. Islam, N. Anila, and A. Gilani, Clinical efficacy of the co-administration of Turmeric and Black seeds (Kalongi) in metabolic syndrome–A double blind randomized controlled trial–TAK-MetS trial. Complementary therapies in medicine, 2015. 23(2): p. 165-174.
39. Moher, D., A. Liberati, J. Tetzlaff, D.G. Altman, and P. Group*, Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Annals of internal medicine, 2009. 151(4): p. 264-269.
40. Hosseini, H., M. Koushki, H. Khodabandehloo, M. Fathi, G. Panahi, M. Teimouri, et al., The effect of resveratrol supplementation on C-reactive protein (CRP) in type 2 diabetic patients: Results from a systematic review and meta-analysis of randomized controlled trials. Complementary therapies in medicine, 2020. 49: p. 102251.
41. Higgins, J.P., D.G. Altman, P.C. Gøtzsche, P. Jüni, D. Moher, A.D. Oxman, et al., The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj, 2011. 343.
42. Borenstein, M., L. Hedges, J. Higgins, and H. Rothstein, Comprehensive meta-analysis version 3 [software] Biostat. Englewood, NJ, 2013.
43. Higgins, J.P., S.G. Thompson, J.J. Deeks, and D.G. Altman, Measuring inconsistency in meta-analyses. Bmj, 2003. 327(7414): p. 557-560.
44. DerSimonian, R. and N. Laird, Meta-analysis in clinical trials. Controlled clinical trials, 1986. 7(3): p. 177-188.
45. Begg, C.B. and J.A. Berlin, Publication bias and dissemination of clinical research. JNCI: Journal of the National Cancer Institute, 1989. 81(2): p. 107-115.
46. Egger, M., G.D. Smith, M. Schneider, and C. Minder, Bias in meta-analysis detected by a simple, graphical test. Bmj, 1997. 315(7109): p. 629-634.
47. Badar, A., H. Kaatabi, A. Bamosa, A. Al-Elq, B. Abou-Hozaifa, F. Lebda, et al., Effect of Nigella sativa supplementation over a one-year period on lipid levels, blood pressure and heart rate in type-2 diabetic patients receiving oral hypoglycemic agents: nonrandomized clinical trial. Annals of Saudi medicine, 2017. 37(1): p. 56-63.
48. Kaatabi, H., A.O. Bamosa, A. Badar, A. Al-Elq, B. Abou-Hozaifa, F. Lebda, et al., Nigella sativa improves glycemic control and ameliorates oxidative stress in patients with type 2 diabetes mellitus: placebo controlled participant blinded clinical trial. PloS one, 2015. 10(2): p. e0113486.
49. Najmi, A., M. Nasiruddin, R. Khan, and S.F. Haque, Therapeutic effect of Nigella sativa in patients of poor glycemic control. Asian J Pharm Clin Res, 2012. 5(3): p. 224-8.
50. Moustafa, H.A.M., L.M. El Wakeel, M.R. Halawa, N.A. Sabri, A.Z. El-Bahy, and A.N. Singab, Effect of Nigella Sativa oil versus metformin on glycemic control and biochemical parameters of newly diagnosed type 2 diabetes mellitus patients. Endocrine, 2019. 65(2): p. 286-294.
51. Kooshki, A., T. Tofighiyan, N. Rastgoo, M.H. Rakhshani, and M. Miri, Effect of Nigella sativa oil supplement on risk factors for cardiovascular diseases in patients with type 2 diabetes mellitus. Phytotherapy Research, 2020. 34(10): p. 2706-2711.
52. Heshmati, J., N. Namazi, M.-R. Memarzadeh, M. Taghizadeh, and F. Kolahdooz, Nigella sativa oil affects glucose metabolism and lipid concentrations in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial. Food Research International, 2015. 70: p. 87-93.
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| Files | ||
| Issue | Vol 1 No 4 (2023) | |
| Section | Review Article(s) | |
| DOI | https://doi.org/10.18502/abi.v1i4.14718 | |
| Keywords | ||
| Diabetes mellitus Dyslipidemia Nigella sativa Meta-analysis | ||
| Rights and permissions | |
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Aliyari M, Hashemy SI, Ghavidel F, Hosseini H. Effect of Nigella sativa Supplementation on Lipid Profile in Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. ABI. 2023;1(4):166-175.
