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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