Clinical trial NCT05697900: Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Keywords: Creatine
Strength
Body Composition
Athletic performance
Nutritional supplementation
Lead sponsor: Dynamical Business and Science Society - DBSS International SAS
Sponsor class: NETWORK
Collaborators: name: INDEPORTES Antioquia
name: CES University
First posted: 2023-01-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.
Primary purpose: TREATMENT

Brief 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 (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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Lower-limb muscle power
timeFrame: Eight weeks
measure: Neuromuscular strength
timeFrame: Eight weeks
measure: Upper-limb muscle strength
timeFrame: Eight weeks
Secondary outcomes:
measure: Body composition
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: INDEPORTES Antioquia
state: Antioquia
Study officials:
affiliation: INDEPORTES Antioquia
name: Andres Rojas-Jaramillo, PhD
role: STUDY_DIRECTOR
affiliation: DBSS International SAS
name: Diego A Bonilla, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.