NCT07521059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Safety of Short Term Creatine Hydrochloride Dosing

Outcome Measures

Primary Outcomes (1)

  • No adverse events

    over 28 days

Study Arms (1)

Group A 750mg/day

EXPERIMENTAL
Dietary Supplement: creatine supplementation

Interventions

creatine supplementationDIETARY_SUPPLEMENT

750 mg/day dosing

Group A 750mg/day

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princeton Consumer Research

Raritan, New Jersey, 08869, United States

Location

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

May 30, 2024

Primary Completion

July 3, 2024

Study Completion

October 1, 2024

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)