NCT07521059CompletedNot Applicable
Short-Term Safety of Low-Dose Creatine Hydrochloride: A 28-Day Single-Arm Pilot Study
Vireo Systems, Inc.1 site in 1 country11 target enrollmentStarted: May 30, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- No adverse events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy adults
Exclusion Criteria
- •consumed creatine supplements in last 30 days significant medical conditions that could affect outcomes (e.g., diabetes)
Arms & Interventions
Group A 750mg/day
Experimental
Intervention: creatine supplementation (Dietary Supplement)
Outcomes
Primary Outcomes
No adverse events
Time Frame: over 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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