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| Name | Class |
|---|---|
| INDEPORTES Antioquia | UNKNOWN |
| CES University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine monohydrate | Active Comparator | 5 g of creatine monohydrate per day for eight weeks |
|
| Creatine hydrochloride | Experimental | 5 g of creatine hydrochloride per day for eight weeks |
|
| Placebo | Placebo Comparator | 5 g of maltodextrin per day for eight weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine Monohydrate | Dietary 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Lower-limb muscle power | Countermovement and drop jump will be performed on contact mat (height in centimeters and time of flight in seconds) | 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). | Eight weeks |
| Upper-limb muscle strength | Maximal shoulder external and internal strength will be measure with a isokinetic dynamometer. | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body composition was measured using dual-energy x-ray absorptiometry. Fat mass and lean mass in kilograms were reported. | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Rojas-Jaramillo, PhD | INDEPORTES Antioquia | Study Director |
| Diego A Bonilla, PhD | DBSS International SAS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INDEPORTES Antioquia | Medellín | Antioquia | 050034 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35268011 | Background | 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. | |
| 33918657 | Background | Bonilla 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. |
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This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.
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This was a double-blinded clinical trial since participants and those assessing the outcomes were blinded to the intervention. All groups were given small metallic plastic bags with five grams of powder identical in size, shape, and color but the placebo contained maltodextrin (Tecnas S.A., Medellín, Colombia).
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| Placebo | Dietary 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 Hydrochloride | Dietary 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). |
|
| 31012939 | Background | Juszczak 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. |
| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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