NCT07176325

Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Vireo Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study aimed to investigate the incidence and severity of GI symptoms associated with daily CM supplementation, with and without a loading phase, in healthy male and female adults.

Detailed description

In a 28-day single-center, single-blind, randomized clinical trial, 24 healthy participants were assigned to either Group A (5 g/day CM) or Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance). Blood and urine samples were collected at baseline and day 28 to assess safety. GI symptoms were recorded via self-report using a structured severity rating scale.

Conditions

• Side Effects of Creatine Monohydrate Dosing

Interventions

Type	Name	Description
OTHER	Creatine Monohydrate	Creatine Monohydrate was dosed based on industry recommendations, with and without a loading dose

Timeline

• Start date: 2024-05-30
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States