Introduction This two-phase clinical study evaluated KleanCREATINE™ (micronized creatine monohydrate) for its pharmacokinetic properties, safety, and efficacy in active men. Materials and methods Phase I was a randomized, open-label, crossover study comparing its pharmacokinetic profile with a marketed creatine monohydrate in 10 healthy men. Phase II was a randomized, double-blind, parallel-arm trial in 52 active men over eight weeks, assessing the safety and efficacy of KleanCREATINE™ on muscle strength, endurance, hypertrophy, body composition, and perceived exertion. Results In Phase I, KleanCREATINE™ demonstrated better pharmacokinetics profile with higher Cmax (8.10 vs 4.80 nmol/UI), quicker Tmax (2 vs 3 hours), and greater relative bioavailability (160.42% in sequence one and 175.45% in sequence two) over the marketed formulation. Phase II revealed significant effectiveness of KleanCREATINE™ over eight weeks: significant reduction in body fat percentage (14.45%), increase in skeletal muscle (10.46%), and enhanced muscle hypertrophy. KleanCREATINE™ showed greater chest press endurance (60.05% vs 49.29%). Perceived exertion decreased more with KleanCREATINE™ (26.4% vs 13.46%). Both formulations demonstrated safety and tolerability, with no adverse effects reported. Conclusions Micronized KleanCREATINE™ exhibited faster absorption, higher bioavailability, and greater efficacy in improving strength, endurance, and body composition compared to standard creatine monohydrate, with an excellent safety profile. These findings suggest KleanCREATINE™ as a promising alternative for athletes and fitness enthusiasts.
Aggarwal et al. (Fri,) studied this question.