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Efficacy of Methika (Trigonella foenum-graecum L.) Seed Powder on Glycemic Control and Insulin Resistance in Adults with Prediabetes: Protocol for a Multicentre Randomized Controlled Clinical Trial
Abstract
• Background Prediabetes offers an opportunity to prevent type 2 diabetes. Methika (fenugreek) seed is widely used as food and has been investigated for glycemic effects. One earlier trial in prediabetes used 10 g daily and reported less progression to diabetes, but the effect on insulin resistance remains uncertain. • Objective To compare 24 weeks of Methika seed powder plus structured lifestyle care with the same lifestyle care alone in adults with prediabetes. • Methods This proposed four-centre, parallel- group, assessor-blinded trial will randomize 240 adults aged 30–65 years with HbA1c-defined prediabetes in a 1:1 ratio. The intervention group will take 5 g of authenticated, quality-tested seed powder in water before breakfast and dinner for 24 weeks. Both groups will receive identical lifestyle counselling and follow-up. The primary outcome will be between-group difference in change in HbA1c from baseline to week 24. Key secondary outcomes will include HOMA-IR, fasting plasma glucose, two- hour glucose after a 75-g oral glucose tolerance test, weight, and adverse events. The primary analysis will follow the intention-to-treat principle with adjustment for baseline HbA1c and centre. • Discussion The trial is designed to test whether a practical dose of seed powder adds measurable benefit to lifestyle care and to examine its effect on fasting insulin resistance. The protocol does not report participant outcomes.
Keywords
Methika; Trigonella foenum- graecum; fenugreek; prediabetes; HbA1c; HOMA- IR; randomized controlled trial
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