Single-arm pilot safety study of creatine hydrochloride in healthy adults
This is a single-arm pilot safety study in 11 healthy adults at a single center. The intervention was 750 mg/day creatine hydrochloride for 28 consecutive days, with baseline as the comparator. The primary outcome was short-term laboratory safety and tolerability, with secondary outcomes including lipid parameters, hematologic indices, renal markers, chemistry analytes, fasting glucose, and serum bicarbonate.
The authors found that fasting glucose increased modestly by 8.1 mg/dL prior to multiplicity adjustment but was not statistically significant after FDR correction and remained within reference ranges. Serum bicarbonate decreased slightly by 2.4 mmol/L; this was statistically detectable in parametric analysis but not consistently supported by nonparametric testing, and values remained within physiological limits. For lipid parameters, hematologic indices, renal markers, and most chemistry analytes, no clinically meaningful changes were observed after adjustment for multiple comparisons.
Limitations noted by the authors include the single-center, single-arm, single-blind design; the small sample size (n=11); the study population limited to healthy adults; and the lack of controlled human safety data specific to creatine hydrochloride. The study did not report adverse events, serious adverse events, or discontinuations.
Practice relevance was not reported, and the authors caution against overstatement regarding generalizability to other populations, long-term safety, and efficacy. The evidence is preliminary and from a small pilot study.
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