CreatineNCT07838805
Changing in Plasma Concentration of a New Form of Creatine
A study testing New Formulation of Creatine (Creamix) and Active Comparator: Creatine Monohydrate in people with Creatine, run by University of Padova at 1 site in Italy.
Trial summary
Creatine is one of the most popular supplements among athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations, improving exercise performance and/or enhancing training adaptations. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Creatine
- What is being tested?
- New Formulation of Creatine (Creamix) and Active Comparator: Creatine Monohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years
- No creatine supplementation in the previous 6 months
- No history of cardiovascular, metabolic, muscular, or neurological diseases
- BMI: 18-30 kg/m²
Who cannot join
- Failure to meet one or more inclusion criteria
- Use of medications or supplements that may affect muscle metabolism or creatine absorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Department of Biomedical Sciences, University of Padua
Padova, PD, 10034
Antonio Paoli, 0498275318, antonio.paoli@unipd.it
About this study
Official title: Time Course of Plasma Creatine Concentrations Following Oral Administration of a Novel Creatine Formulation
Creatine is one of the most popular supplements among athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations, improving exercise performance and/or enhancing training adaptations. Research has also indicated that creatine supplementation may improve post-exercise recovery and may help with injury prevention, thermoregulation, rehabilitation, and neuroprotection in cases of concussion and/or spinal cord injury. Several clinical applications of creatine supplementation have also been investigated, particularly in relation to neurodegenerative diseases (e.g., muscular dystrophy, Parkinson's disease, and Huntington's disease), diabetes, osteoarthritis, fibromyalgia, aging, cerebral and cardiac ischemia, adolescent depression, and pregnancy. The most commonly studied form of creatine in the literature is creatine monohydrate. The uptake of creatine first involves its absorption into the bloodstream and subsequently its uptake by target tissues. Plasma creatine levels typically peak about 60 minutes after the oral ingestion of creatine monohydrate. An initial increase in plasma creatine levels, followed by a reduction, can indirectly suggest increased creatine uptake by target tissues. However, in recent years, new formulations of creatine have been developed to improve its solubility, stability, or bioavailability. Therefore, it is of interest to evaluate whether these formulations differ in absorption kinetics from creatine monohydrate, the reference form in the literature. The aim is to compare the blood absorption of a new formulation of creatine (containing Creatine Phosphate, Creatine Pyruvate, Creatine Hydrochloride) with that of traditional creatine monohydrate. It is hypothesized that the new formulation has a pharmacokinetic profile similar to that of creatine monohydrate.
Read the detailed description
Participants will arrive at the laboratory after an overnight fast (8-10 h), having consumed their last meal no later than 20:00 h on the previous day. They will be instructed to refrain from any structured physical training within 48 h prior to the study and to abstain from alcohol and caffeine from 20:00 h on the previous day. During the entire experimental session, no food, caffeine or caloric beverages will be allowed. Water intake will be standardized within predefined limits (250 mL prior to baseline and up to 700 mL during the session). Creatine, both new formulation and standard, will be administered dissolved in water, and no additional fluids will be allowed for at least 20 min following ingestion to minimize variability in gastrointestinal absorption. Creatine monohydrate will be administered orally as a single dose (5 g) and the new formulation as a single dose (10g), both dissolved in 200 mL of water. The exact time of ingestion will be recorded and defined as time zero (T0). Blood samples for plasma analysis will be collected at baseline and at 30, 60, 90, 120, and 180 minutes following creatine administration, in accordance with previously published protocols (Jäger et al., 2007; Harris et al., 2004). Participants will remain seated for at least 10 minutes before each blood draw. Venous blood will be collected from an antecubital vein into EDTA-containing tubes. Blood samples will be centrifuged within 30 min of collection at 2,000 rcf for 15 min at 4°C. Plasma will be carefully aliquoted into pre-labeled microtubes and will be stored at -80°C until analysis. All samples from the same participant will be analyzed in the same analytical run to minimize inter-assay variability. Then, participants who took the new formulation will be switched with the standard and vice versa.
- Conditions
- Creatine
- Being tested
- New Formulation of Creatine (Creamix), Active Comparator: Creatine Monohydrate
- Keywords
- creatine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Formulation of Creatine (Creamix)Dietary supplement
Participants will arrive at the laboratory after an overnight fast (8-10 h), having consumed their last meal no later than 20:00 h on the previous day. Participants will be asked to refrain from creatine supplementation for at least 2-4 weeks prior to the experimental session. During the entire experimental session, no food, caffeine or caloric beverages will be allowed. Water intake will be standardized within predefined limits (250 mL prior to baseline and up to 500 mL during the session). Creamix (10g) will be administered dissolved in water, and no additional fluids will be allowed for at least 20 min following ingestion to minimize variability in gastrointestinal absorption. The exact time of ingestion will be recorded and defined as time zero (T0). Blood samples for plasma analysis will be collected at baseline and at 30, 60, 90, 120, and 180 minutes following creatine administration, in accordance with previously published protocols (Jäger et al., 2007; Harris et al., 2004).
Active Comparator: Creatine MonohydrateDietary supplement
Participants will arrive at the laboratory after an overnight fast (8-10 h), having consumed their last meal no later than 20:00 h on the previous day. Participants will be asked to refrain from creatine supplementation for at least 2-4 weeks prior to the experimental session. During the entire experimental session, no food, caffeine or caloric beverages will be allowed. Water intake will be standardized within predefined limits (250 mL prior to baseline and up to 500 mL during the session). Creatine (5g) will be administered dissolved in water, and no additional fluids will be allowed for at least 20 min following ingestion to minimize variability in gastrointestinal absorption. The exact time of ingestion will be recorded and defined as time zero (T0). Blood samples for plasma analysis will be collected at baseline and at 30, 60, 90, 120, and 180 minutes following creatine administration, in accordance with previously published protocols (Jäger et al., 2007; Harris et al., 2004).
| Study group | Role | What they receive |
|---|---|---|
| New formulation of creatine (Creamix) group | Experimental | Supplemented participants will receive 10g of new formulation of creatine dissolved in 200 mL of water Receives: Dietary Supplement: New Formulation of Creatine (Creamix) |
| Creatine Monohydrate group | Active comparator | Supplemented participants will receive 5g of creatine monohydrate dissolved in 200 mL of water Receives: Dietary Supplement: Active Comparator: Creatine Monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total plasma creatine concentration
Total plasma creatine concentration will be determined using a commercially available enzymatic assay kit (Creatine Assay Kit, Abcam, ab65339), according to the manufacturer's instructions. The assay is based on an enzymatic reaction that converts creatine (and phosphocreatine) into a detectable product, generating a colorimetric signal proportional to creatine concentration. Absorbance will be measured spectrophotometrically at the recommended wavelength. A standard calibration curve will be generated using creatine standards provided with the kit, and sample concentrations will be calculated by interpolation. All plasma samples will be analyzed in duplicate, and quality control samples will be included to ensure assay reliability. Although the assay measures total creatine, the contribution of phosphocreatine in plasma is considered negligible; therefore, measured values will primarily reflect circulating free creatine.
Measured: Blood samples for plasma analysis will be collected at six specific timepoints: baseline (T0) and at 30 (T1), 60 (T2), 90 (T3), 120 (T4), and 180 (T5) minutes following creatine administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start17 Sep 2026 (estimated)
- Primary completion17 Oct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CreatineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Paoli, Study director, University of Padua Department of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838805
- Sponsor's protocol ID
- CREATINE
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Plasma Creatine Concentrations Following Oral Administration of a Novel Creatine Formulation
- ClinicalTrials.gov ID
- NCT07838805
- Acronym / sponsor ID
- CREATINE
- Conditions
- Creatine
- Keywords
- creatine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 17 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Sep 2026 (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.
Creatine is one of the most popular supplements among athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations, improving exercise performance and/or enhancing training adaptations. Research has also indicated that creatine supplementation may improve post-exercise recovery and may help with injury prevention, thermoregulation, rehabilitation, and neuroprotection in cases of concussion and/or spinal cord injury. Several clinical applications of creatine supplementation have also been investigated, particularly in relation to neurodegenerative diseases (e.g., muscular dystrophy, Parkinson's disease, and Huntington's disease), diabetes, osteoarthritis, fibromyalgia, aging, cerebral and cardiac ischemia, adolescent depression, and pregnancy. The most commonly studied form of creatine in the literature is creatine monohydrate. The uptake of creatine first involves its absorption into the bloodstream and subsequently its uptake by target tissues. Plasma creatine levels typically peak about 60 minutes after the oral ingestion of creatine monohydrate. An initial increase in plasma creatine levels, followed by a reduction, can indirectly suggest increased creatine uptake by target tissues. However, in recent years, new formulations of creatine have been developed to improve its solubility, stability, or bioavailability. Therefore, it is of interest to evaluate whether these formulations differ in absorption kinetics from creatine monohydrate, the reference form in the literature. The aim is to compare the blood absorption of a new formulation of creatine (containing Creatine Phosphate, Creatine Pyruvate, Creatine Hydrochloride) with that of traditional creatine monohydrate. It is hypothesized that the new formulation has a pharmacokinetic profile similar to that of creatine monohydrate.
Detailed description
Participants will arrive at the laboratory after an overnight fast (8-10 h), having consumed their last meal no later than 20:00 h on the previous day. They will be instructed to refrain from any structured physical training within 48 h prior to the study and to abstain from alcohol and caffeine from 20:00 h on the previous day. During the entire experimental session, no food, caffeine or caloric beverages will be allowed. Water intake will be standardized within predefined limits (250 mL prior to baseline and up to 700 mL during the session). Creatine, both new formulation and standard, will be administered dissolved in water, and no additional fluids will be allowed for at least 20 min following ingestion to minimize variability in gastrointestinal absorption. Creatine monohydrate will be administered orally as a single dose (5 g) and the new formulation as a single dose (10g), both dissolved in 200 mL of water. The exact time of ingestion will be recorded and defined as time zero (T0). Blood samples for plasma analysis will be collected at baseline and at 30, 60, 90, 120, and 180 minutes following creatine administration, in accordance with previously published protocols (Jäger et al., 2007; Harris et al., 2004). Participants will remain seated for at least 10 minutes before each blood draw. Venous blood will be collected from an antecubital vein into EDTA-containing tubes. Blood samples will be centrifuged within 30 min of collection at 2,000 rcf for 15 min at 4°C. Plasma will be carefully aliquoted into pre-labeled microtubes and will be stored at -80°C until analysis. All samples from the same participant will be analyzed in the same analytical run to minimize inter-assay variability. Then, participants who took the new formulation will be switched with the standard and vice versa.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New formulation of creatine (Creamix) group | Experimental | Dietary Supplement: New Formulation of Creatine (Creamix)Supplemented participants will receive 10g of new formulation of creatine dissolved in 200 mL of water |
| Creatine Monohydrate group | Active comparator | Dietary Supplement: Active Comparator: Creatine MonohydrateSupplemented participants will receive 5g of creatine monohydrate dissolved in 200 mL of water |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 35 years
- No creatine supplementation in the previous 6 months
- No history of cardiovascular, metabolic, muscular, or neurological diseases
- BMI: 18-30 kg/m²
Key exclusion criteria (2 listed)
- Failure to meet one or more inclusion criteria
- Use of medications or supplements that may affect muscle metabolism or creatine absorption.
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 |
|---|---|---|
| New Formulation of Creatine (Creamix)Participants will arrive at the laboratory after an overnight fast (8-10 h), having consumed their last meal no later than 20:00 h on the previous day. Participants will be asked to refrain from creatine supplementation for at least 2-4 weeks prior to the experimental session. During the entire experimental session, no food, caffeine or caloric beverages will be allowed. Water intake will be standardized within predefined limits (250 mL prior to baseline and up to 500 mL during the session). Creamix (10g) will be administered dissolved in water, and no additional fluids will be allowed for at least 20 min following ingestion to minimize variability in gastrointestinal absorption. The exact time of ingestion will be recorded and defined as time zero (T0). Blood samples for plasma analysis will be collected at baseline and at 30, 60, 90, 120, and 180 minutes following creatine administration, in accordance with previously published protocols (Jäger et al., 2007; Harris et al., 2004). | Dietary supplement | New formulation of creatine (Creamix) group |
| Active Comparator: Creatine MonohydrateParticipants will arrive at the laboratory after an overnight fast (8-10 h), having consumed their last meal no later than 20:00 h on the previous day. Participants will be asked to refrain from creatine supplementation for at least 2-4 weeks prior to the experimental session. During the entire experimental session, no food, caffeine or caloric beverages will be allowed. Water intake will be standardized within predefined limits (250 mL prior to baseline and up to 500 mL during the session). Creatine (5g) will be administered dissolved in water, and no additional fluids will be allowed for at least 20 min following ingestion to minimize variability in gastrointestinal absorption. The exact time of ingestion will be recorded and defined as time zero (T0). Blood samples for plasma analysis will be collected at baseline and at 30, 60, 90, 120, and 180 minutes following creatine administration, in accordance with previously published protocols (Jäger et al., 2007; Harris et al., 2004). | Dietary supplement | Creatine Monohydrate group |
Primary outcome
Total plasma creatine concentration
Time frame: Blood samples for plasma analysis will be collected at six specific timepoints: baseline (T0) and at 30 (T1), 60 (T2), 90 (T3), 120 (T4), and 180 (T5) minutes following creatine administration.
Total plasma creatine concentration will be determined using a commercially available enzymatic assay kit (Creatine Assay Kit, Abcam, ab65339), according to the manufacturer's instructions. The assay is based on an enzymatic reaction that converts creatine (and phosphocreatine) into a detectable product, generating a colorimetric signal proportional to creatine concentration. Absorbance will be measured spectrophotometrically at the recommended wavelength. A standard calibration curve will be generated using creatine standards provided with the kit, and sample concentrations will be calculated by interpolation. All plasma samples will be analyzed in duplicate, and quality control samples will be included to ensure assay reliability. Although the assay measures total creatine, the contribution of phosphocreatine in plasma is considered negligible; therefore, measured values will primarily reflect circulating free creatine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Creatine
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Recruiting
Microcurrent Therapy and the Post-Exercise Physiological Response (MENS_PE)
Muscle Fatigue
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
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.
Antonio Paoli study director
University of Padua Department of Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Formulation of Creatine (Creamix) and Active Comparator: Creatine Monohydrate in people with Creatine, run by University of Padova at 1 site in Italy.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Paoli (0498275318, antonio.paoli@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total plasma creatine concentration (time frame: Blood samples for plasma analysis will be collected at six specific timepoints: baseline (T0) and at 30 (T1), 60 (T2), 90 (T3), 120 (T4), and 180 (T5) minutes following creatine administration.). 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 24 Sep 2026.