A randomized,double-blind placebo-controlled add-on trial to assess the efficacy,safety, and anti-atherogenic effect of spirulina platensis in patients with inadequately controlled type 2 diabetes mellitus |
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Authors: | Sahar rajabzadeh Karizi Fatemeh Armanmehr Hamideh Ghodrati Azadi Hojjat Shadman Zahroodi AmirAli Moodi Ghalibaf Bibi Sedigheh Fazly Bazzaz Mohammadreza Abbaspour Javad Boskabadi Saeid Eslami Zhila Taherzadeh |
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Institution: | 1. Department of Pharmacodynamy and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran;2. Department of Basic Sciences, Faculty of Veterinary Medicine, Ferdowsi University of Mashhad, Mashhad, Iran;3. Student Research Committee, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran;4. Biotechnology Research Center, Institute of Pharmaceutical Technology, Mashhad University of Medical Sciences, Mashhad, Iran;5. Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran;6. Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran;7. Department of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran;8. Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran |
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Abstract: | The efficacy of spirulina platensis (S. platensis) as an add-on therapy to metformin and its effect on atherogenic keys in patients with uncontrolled Type 2 Diabetes Mellitus (T2DM) was evaluated. Sixty patients were randomly assigned to S. platensis (2 g/day) or placebo group for three months while continuing metformin as their usual treatment. The efficacy of S. platensis was determined using the pre- and post-intervention HbA1c levels (primary outcome) as well as tracking FBS and lipid profiles levels (TC, LDL-C, TG, and HDL-C) as secondary outcomes at the different treatment time points (0,30,60,90 days). During the three–month intervention period, supplementation with S. platensis resulted in a significant lowering of HbA1c (↓1.43, p < 0.001) and FBS (↓ 24.94 mg/dL, p < 001) levels. Mean TG in the intervention group was found to be significantly lower in the intervention group than in controls (p < 0.001). Total cholesterol (TC) and its fraction, LDL-C, exhibited a fall (↓41.36 mg/dL and ↓38.4 mg/dL, respectively; p < 0.001) coupled with a marginal increase in the level of HDL-C (↑3 mg/dL; p < 0.001). Add-on therapy with S. platensis was superior to metformin regarding long-term glucose regulation and controlling blood glucose levels of subjects with T2DM. Also, as a functional supplement, S. platensis has a beneficial effect on atherogenic keys (TG and HDL-C) with no adverse events. |
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Keywords: | atherogenic keys fasting blood glucose hemoglobin A1C Spirulina platensis type 2 diabetes |
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