Side Effects of Creatine Monohydrate DosingNCT07176325
Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation
An observational study of Side Effects of Creatine Monohydrate Dosing, run by Vireo Systems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Side Effects of Creatine Monohydrate Dosing
- What is being tested?
- Creatine Monohydrate
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 3 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy male and females ages 18-60
Who may be able to join
- ○ 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.
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- 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.
Who cannot join
- ○ 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Princeton Consumer Research
Raritan, New Jersey, 08869
About this study
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.
Read the 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.
- Being tested
- Creatine Monohydrate
- Keywords
- creatine monohydrate, gastrointestinal symptoms, supplementation, dosing regimen, tolerability, compliance, loading dose
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateOther
Creatine Monohydrate was dosed based on industry recommendations, with and without a loading dose
| Study group | Role | What they receive |
|---|---|---|
| Group A (5 g/day CM) | No Loading Group Receives: Other: Creatine Monohydrate | |
| Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance) | Loading Group Receives: Other: Creatine Monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal distress
Gastrointestinal effects are well known, particularly at higher doses.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 May 2024
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Side Effects of Creatine Monohydrate DosingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vireo Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176325
- Sponsor's protocol ID
- VIRUSE1R
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are looking at aggregate trends in the data
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation
- ClinicalTrials.gov ID
- NCT07176325
- Acronym / sponsor ID
- VIRUSE1R
- Keywords
- creatine monohydrate, gastrointestinal symptoms, supplementation, dosing regimen, tolerability, compliance, loading dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vireo Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (5 g/day CM) | – | Other: Creatine MonohydrateNo Loading Group |
| Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance) | – | Other: Creatine MonohydrateLoading Group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy male and females ages 18-60
Key inclusion criteria (9 listed)
- ○ Subjects must be healthy males or females, aged 18 to 60 inclusive at the time of screening.
Key exclusion criteria (12 listed)
- ○ Subjects who are participating in another Clinical Trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohydrateCreatine Monohydrate was dosed based on industry recommendations, with and without a loading dose | Other | Group A (5 g/day CM), Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance) |
Primary outcome
Gastrointestinal distress
Time frame: 28 days
Gastrointestinal effects are well known, particularly at higher doses.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. We are looking at aggregate trends in the data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Side Effects of Creatine Monohydrate Dosing, run by Vireo Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal distress (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.