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

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.

Study Overview

• Status: Completed
• Conditions: Side Effects of Creatine Monohydrate Dosing
• Intervention / Treatment: Other: Creatine Monohydrate

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Princeton Consumer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

healthy male and females ages 18-60

Description

Inclusion Criteria:

• ○ Subjects must be healthy males or females, aged 18 to 60 inclusive at the time of screening.

  • Subjects must be able to understand the study, agree to the requirements and restrictions, and be willing to give voluntary consent to participate in the study.
  • Subjects are willing to have up to two (2) blood collections, one at Visit 2 and Visit 3.
  • Subjects are willing to provide a urine sample that is collected over 24 hours. This entails collecting all urine in a 24-hour period in a container.
  • Subject is willing to fast for 12 hours before the Baseline visit (second visit). Water is permitted.
  • Subject is willing to have waist measurements taken with calipers and willing to wear clothing that allows easy access to their waist.
  • Female subjects of childbearing potential must agree to one of the following methods of birth control through the duration of the study. Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream); intra-uterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 month prior to screening visit; vasectomized partner or bilateral insertion of Essure® implants (or analogous) for at least 6 months prior to the screening visit; to be considered a female of non- childbearing potential, subject must have had a bilateral tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 1 year prior to the screening visit.
  • Subject is willing to comply with the study restrictions.
  • Subjects is willing to maintain their current exercise regimen and their current diet while on the study.

Exclusion Criteria:

• ○ Subjects who are participating in another Clinical Trial.

  • Subjects who faint during blood collection, or who have a phobia of needles, or a phobia of blood.
  • Subjects who are weightlifters.
  • Females who are pregnant or lactating (verbal confirmation only).
  • Subject who has taken any creatine supplements in the last 30 days.
  • Subjects with history of cancer (except localized skin cancer without metastases) within 5 years prior to the screening visit.
  • Subject has diabetes (insulin dependent or not) or any immune deficiency disease such as HIV/AIDS, etc.
  • Subject has any medical condition whether treating with mediation or not including hypertension (high blood pressure), hepatitis, any kidney disease or disorders, or musculoskeletal disorders. Note: if there are any significantly abnormal results for the BUN/creatinine screening labs the subject will be dropped.
  • Subject is taking a medication that would preclude participation in the study per the Principal Investigator.
  • Subjects with recent or current medical condition that may significantly impact the subject or the validity of the study results in the opinion of the Investigator.
  • Subjects who have a known or suspected allergy or sensitivity to creatine.
  • Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study visit.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A (5 g/day CM); No Loading Group	Other: Creatine Monohydrate; Creatine Monohydrate was dosed based on industry recommendations, with and without a loading dose
Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance); Loading Group	Other: Creatine Monohydrate; Creatine Monohydrate was dosed based on industry recommendations, with and without a loading dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal distress	Gastrointestinal effects are well known, particularly at higher doses.	28 days

Collaborators and Investigators

• Sponsor: Vireo Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): July 3, 2024

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: creatine monohydrate, gastrointestinal symptoms, supplementation, dosing regimen, tolerability, compliance, loading dose
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Compliance; Amino Acids, Peptides, and Proteins; Organic Chemicals; Amino Acids; Guanidines; Amidines; Creatine
• Other Study ID Numbers: VIRUSE1R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are looking at aggregate trends in the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No