Efficacy and safety of a novel trigonelline-based standardized fenugreek seed extract (IDM01) capsules in recreationally active adults: A randomized, double-blind, and placebo-controlled clinical study

Context: Fatigue, stress, and cognitive performance are commonly affected in recreationally active adults who engage in regular exercise. Nutritional interventions may improve both physical and cognitive performance. IDM01, a standardized trigonelline-rich fenugreek ( Trigonella foenum-graecum L.) seed extract, exhibits potential cognitive-supportive properties. Aims: To evaluate the efficacy and safety of IDM01 on fatigue, cognition, and mood in recreationally active adults. Settings and Design: A randomized, double-blind, placebo-controlled, parallel-arm study. Methods and Materials: The study was conducted among healthy men and women aged 18–50 years who underwent resistance training 3–5 times per week for ≥6 months. Participants ( n = 120) received either IDM01 (500 mg/day) or placebo for 8 weeks. The primary endpoint was the change in fatigue score assessed using the Multidimensional Fatigue Symptom Inventory–Short Form. Secondary measures included perceived exertion (Borg CR-10), motivation to move and rest, mood states (alertness, stress, and tranquillity), cognitive performance after mental exercise, and hair cortisol concentration. Safety was monitored based on the laboratory parameters and adverse event (AE) recordings. Results: Of the 120 participants, 105 completed the study. IDM01 significantly improved motivation and cognitive performance, reduced stress ( P < 0.05) compared with placebo, and significantly improved alertness from baseline (within the group). No serious AEs were observed. Conclusions: Eight weeks of IDM01 supplementation significantly improved volitional energy, alertness, stress resilience, and cognitive performance, supporting its role as a safe and effective preworkout nutraceutical for enhancing physical and mental performance in healthy adults.