Healthy LifestyleCrM_CrHClNCT05697900
Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes
A study testing Creatine Monohydrate and Creatine Hydrochloride in people with Healthy Lifestyle, run by Dynamical Business and Science Society - DBSS International SAS at 1 site in Colombia.
Trial summary
A triple-arm double-blinded placebo-controlled repeated-measures randomized clinical trial in Colombian elite team-sport athletes. The aim is to evaluate the effects on strength-related parameters and body composition after eight weeks of supplementation with creatine monohydrate (CrM) and creatine hydrochloride… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Creatine Monohydrate and Creatine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jun 2021to 22 Aug 2022
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Practicing team sports at the competitive level (handball and softball)
- Having at least one year of competitive sports training experience (including strength training at least three times a week),
- Being attended at INDEPORTES Antioquia.
Who cannot join
- Those who do not wish to participate voluntarily (do not sign informed consent),
- Those who were taking nutritional supplements (including creatine) eight weeks prior to the start of the study,
- Those who had a diagnosed pathology or health issues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes: A Three-arm Placebo-controlled Randomized Clinical Trial
A triple-arm double-blinded placebo-controlled repeated-measures randomized clinical trial in Colombian elite team-sport athletes. The aim is to evaluate the effects on strength-related parameters and body composition after eight weeks of supplementation with creatine monohydrate (CrM) and creatine hydrochloride (Cr-HCl). The study will be reported following the Consolidated Standards of Reporting Trials (CONSORT) extension to Multi-Arm Parallel-Group Randomized Trials. All variables will be measured at baseline and after eight weeks.
Read the detailed description
Creatine monohydrate (CrM) is the most studied nutritional supplement and, therefore, one of the most popular ergogenic nutritional aids for athletes. Studies have shown that CrM supplementation increases intramuscular creatine concentrations which enhances exercise performance and improves body composition in different populations (from young athletes to older adults).
It is important to note that the U.S. Food and Drug Administration (FDA) have recognized CrM as a safe ingredient (Generally Recognized as Safe, GRAS - No. GRN 000931). In spite of this, other forms such as creatine chloride (Cr-HCl) have been marketed as a more bioavailable sources of creatine. Since there are not studies that rigorously compare the effects of CrM versus Cr-HCl on physical performance and body composition, the aim of this study is to evaluate the effects of a 8-week supplementation protocol with the two forms of creatine (comparing to placebo) on neuromuscular strength and body composition in Colombian elite team-sport athletes.
- Conditions
- Healthy Lifestyle
- Being tested
- Creatine Monohydrate, Placebo, Creatine Hydrochloride
- Keywords
- Creatine, Strength, Body Composition, Athletic performance, Nutritional supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
The CrM group supplemented the diet with five grams of micronized creatine monohydrate per day for eight weeks. The CrM supplement was fully dissolved in ≈500 mL of water and drank immediately after each training session (in the morning on non-training days).
PlaceboDietary supplement
A placebo group intakes five grams of maltodextrin daily throughout the study. The placebo supplement was fully dissolved in ≈500 mL of water and drank immediately after each training session (in the morning on non-training days).
Creatine HydrochlorideDietary supplement
The Cr-HCl group supplemented the diet with five grams of micronized creatine monohydrate per day for eight weeks. The Cr-HCl supplement was fully dissolved in ≈500 mL of water and drank immediately after each training session (in the morning on non-training days).
| Study group | Role | What they receive |
|---|---|---|
| Creatine monohydrate | Active comparator | 5 g of creatine monohydrate per day for eight weeks Receives: Dietary Supplement: Creatine Monohydrate |
| Creatine hydrochloride | Experimental | 5 g of creatine hydrochloride per day for eight weeks Receives: Dietary Supplement: Creatine Hydrochloride |
| Placebo | Placebo comparator | 5 g of maltodextrin per day for eight weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-limb muscle power
Countermovement and drop jump will be performed on contact mat (height in centimeters and time of flight in seconds)
Measured: Eight weeks
Neuromuscular strength
The load-velocity profile in squat and bench press exercises will be obtained with a linear position transducer (load in kilograms versus mean propulsive velocity in meters per second).
Measured: Eight weeks
Upper-limb muscle strength
Maximal shoulder external and internal strength will be measure with a isokinetic dynamometer.
Measured: Eight weeks
Secondary outcomes (1)
Body composition
Body composition was measured using dual-energy x-ray absorptiometry. Fat mass and lean mass in kilograms were reported.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jun 2021
- Primary completion15 Feb 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SAS
- Sponsor type
- Research network
- Collaborators
- INDEPORTES Antioquia, CES University
- Responsible party
- Sponsor
- Investigators
- Andres Rojas-Jaramillo, PhD, Study director, INDEPORTES AntioquiaDiego A Bonilla, PhD, Study chair, DBSS International SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697900
- Sponsor's protocol ID
- Acta161_N°994
- Acronym
- CrM_CrHCl
- Status last verified
- Jan 2023
- First submitted
- 31 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreider RB, Jager R, Purpura M. Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. Nutrients. 2022 Feb 28;14(5):1035. doi: 10.3390/nu14051035.
PubMed 35268011Bonilla DA, Kreider RB, Stout JR, Forero DA, Kerksick CM, Roberts MD, Rawson ES. Metabolic Basis of Creatine in Health and Disease: A Bioinformatics-Assisted Review. Nutrients. 2021 Apr 9;13(4):1238. doi: 10.3390/nu13041238.
PubMed 33918657Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.
PubMed 31012939
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes: A Three-arm Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05697900
- Acronym / sponsor ID
- CrM_CrHCl / Acta161_N°994
- Conditions
- Healthy Lifestyle
- Keywords
- Creatine, Strength, Body Composition, Athletic performance, Nutritional supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SASResearch network
- Collaborators
- INDEPORTES Antioquia, CES University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 26 Jan 2023 (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.
A triple-arm double-blinded placebo-controlled repeated-measures randomized clinical trial in Colombian elite team-sport athletes. The aim is to evaluate the effects on strength-related parameters and body composition after eight weeks of supplementation with creatine monohydrate (CrM) and creatine hydrochloride (Cr-HCl). The study will be reported following the Consolidated Standards of Reporting Trials (CONSORT) extension to Multi-Arm Parallel-Group Randomized Trials. All variables will be measured at baseline and after eight weeks.
Detailed description
Creatine monohydrate (CrM) is the most studied nutritional supplement and, therefore, one of the most popular ergogenic nutritional aids for athletes. Studies have shown that CrM supplementation increases intramuscular creatine concentrations which enhances exercise performance and improves body composition in different populations (from young athletes to older adults).
It is important to note that the U.S. Food and Drug Administration (FDA) have recognized CrM as a safe ingredient (Generally Recognized as Safe, GRAS - No. GRN 000931). In spite of this, other forms such as creatine chloride (Cr-HCl) have been marketed as a more bioavailable sources of creatine. Since there are not studies that rigorously compare the effects of CrM versus Cr-HCl on physical performance and body composition, the aim of this study is to evaluate the effects of a 8-week supplementation protocol with the two forms of creatine (comparing to placebo) on neuromuscular strength and body composition in Colombian elite team-sport athletes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.
| Arm | Type | Receives |
|---|---|---|
| Creatine monohydrate | Active comparator | Dietary Supplement: Creatine Monohydrate5 g of creatine monohydrate per day for eight weeks |
| Creatine hydrochloride | Experimental | Dietary Supplement: Creatine Hydrochloride5 g of creatine hydrochloride per day for eight weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo5 g of maltodextrin per day for eight weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Practicing team sports at the competitive level (handball and softball)
- Having at least one year of competitive sports training experience (including strength training at least three times a week),
- Being attended at INDEPORTES Antioquia.
Key exclusion criteria (3 listed)
- Those who do not wish to participate voluntarily (do not sign informed consent),
- Those who were taking nutritional supplements (including creatine) eight weeks prior to the start of the study,
- Those who had a diagnosed pathology or health issues.
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 MonohydrateThe CrM group supplemented the diet with five grams of micronized creatine monohydrate per day for eight weeks. The CrM supplement was fully dissolved in ≈500 mL of water and drank immediately after each training session (in the morning on non-training days). | Dietary supplement | Creatine monohydrate |
| PlaceboA placebo group intakes five grams of maltodextrin daily throughout the study. The placebo supplement was fully dissolved in ≈500 mL of water and drank immediately after each training session (in the morning on non-training days). | Dietary supplement | Placebo |
| Creatine HydrochlorideThe Cr-HCl group supplemented the diet with five grams of micronized creatine monohydrate per day for eight weeks. The Cr-HCl supplement was fully dissolved in ≈500 mL of water and drank immediately after each training session (in the morning on non-training days). | Dietary supplement | Creatine hydrochloride |
Primary outcome
Lower-limb muscle power
Time frame: Eight weeks
Countermovement and drop jump will be performed on contact mat (height in centimeters and time of flight in seconds)
Neuromuscular strength
Time frame: Eight weeks
The load-velocity profile in squat and bench press exercises will be obtained with a linear position transducer (load in kilograms versus mean propulsive velocity in meters per second).
Upper-limb muscle strength
Time frame: Eight weeks
Maximal shoulder external and internal strength will be measure with a isokinetic dynamometer.
1 secondary outcome
Body composition
Time frame: Eight weeks
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 26 Jan 2023.
- Background: PubMed 35268011Kreider RB, Jager R, Purpura M. Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. Nutrients. 2022 Feb 28;14(5):1035. doi: 10.3390/nu14051035.
- Background: PubMed 33918657Bonilla DA, Kreider RB, Stout JR, Forero DA, Kerksick CM, Roberts MD, Rawson ES. Metabolic Basis of Creatine in Health and Disease: A Bioinformatics-Assisted Review. Nutrients. 2021 Apr 9;13(4):1238. doi: 10.3390/nu13041238.
- Background: PubMed 31012939Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.
- Individual participant dataSharing planned: No
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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.
Andres Rojas-Jaramillo, PhD study director
INDEPORTES Antioquia
Diego A Bonilla, PhD study chair
DBSS International SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate and Creatine Hydrochloride in people with Healthy Lifestyle, run by Dynamical Business and Science Society - DBSS International SAS at 1 site in Colombia.
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 3 inclusion and 3 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 26 Jan 2023. 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 Colombia. 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. Some participants in this study may receive a placebo. 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?
Lower-limb muscle power (time frame: Eight weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697900, which also lists 3 linked publications.
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 26 Jan 2023.