Short-Term Safety of Low-Dose Creatine Hydrochloride: A 28-Day Single-Arm Pilot Study

NCT07521059 — Not applicable, Completed, 11 participants, Vireo Systems, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07521059
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	11 (Actual)
Sponsor	Vireo Systems, Inc. (Industry)
Conditions	Safety of Short Term Creatine Hydrochloride Dosing
Interventions	creatine supplementation (Dietary supplement)
Dates	start 2024-05-30, primary completion 2024-07-03, completion 2024-10-01, first posted 2026-04-09, last updated 2026-04-09
Locations	1 site in United States

-Summary

Background: Creatine monohydrate (typically 5-20 g/day) has a well-established safety profile across diverse populations. Creatine hydrochloride (CR-HCl) is a highly soluble creatine formulation that may allow effective supplementation at substantially lower doses (750 mg - 3 g/day); however, controlled human safety data specific to CR-HCl remain limited.

Objective: To evaluate the short-term laboratory safety and tolerability of low-dose CR-HCl supplementation administered for 28 days in healthy adults.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Group A 750mg/day	Experimental	Dietary Supplement: creatine supplementation

creatine supplementation (Dietary supplement): 750 mg/day dosing

+Outcome measures

Primary outcomes

No adverse events [over 28 days]

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* consumed creatine supplements in last 30 days significant medical conditions that could affect outcomes (e.g., diabetes)

+Locations (1)

Facility	City	Country	Status
Princeton Consumer Research	Raritan, New Jersey	United States