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

September 8, 2025 updated by: Vireo Systems, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal distress
Time Frame: 28 days
Gastrointestinal effects are well known, particularly at higher doses.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vireo Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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