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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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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.… Click to show full 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.

Keywords: effect; diabetes mellitus; efficacy; type diabetes; platensis; spirulina platensis

Journal Title: Phytotherapy Research
Year Published: 2023

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