CrM_CrHCl: Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes

• Sponsor: Dynamical Business and Science Society - DBSS International SAS (Other)
• Overall Status: Completed
• CT.gov ID: NCT05697900
• Collaborator: INDEPORTES Antioquia (Other), CES University (Other)
• Enrollment: 48
• Location: 1
• Arms: 3
• Actual Duration (Months): 14.7
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Lifestyle	Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Placebo; Dietary Supplement: Creatine Hydrochloride	N/A

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

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.
• Masking: Double (Participant, Investigator)
• Masking Description: 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).
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Feb 15, 2022
• Actual Study Completion Date: Aug 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Creatine monohydrate 5 g of creatine monohydrate per day for eight weeks	Dietary Supplement: Creatine Monohydrate; 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).
Experimental: Creatine hydrochloride 5 g of creatine hydrochloride per day for eight weeks	Dietary Supplement: Creatine Hydrochloride; 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).
Placebo Comparator: Placebo 5 g of maltodextrin per day for eight weeks	Dietary Supplement: Placebo; 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).

Outcome Measures

Primary Outcome Measures

1. Lower-limb muscle power [Eight weeks]

   Countermovement and drop jump will be performed on contact mat (height in centimeters and time of flight in seconds)

2. Neuromuscular strength [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).

3. Upper-limb muscle strength [Eight weeks]

   Maximal shoulder external and internal strength will be measure with a isokinetic dynamometer.

Secondary Outcome Measures

1. Body composition [Eight weeks]

   Body composition was measured using dual-energy x-ray absorptiometry. Fat mass and lean mass in kilograms were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INDEPORTES Antioquia	Medellín	Antioquia	Colombia	050034

Sponsors and Collaborators

• Dynamical Business and Science Society - DBSS International SAS
• INDEPORTES Antioquia
• CES University

Investigators

• Study Director: Andres Rojas-Jaramillo, PhD, INDEPORTES Antioquia
• Study Chair: Diego A Bonilla, PhD, DBSS International SAS

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Dynamical Business and Science Society - DBSS International SAS
• ClinicalTrials.gov Identifier: NCT05697900
• Other Study ID Numbers: Acta161_N°994
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dynamical Business and Science Society - DBSS International SAS: Creatine; Strength; Body Composition; Athletic performance; Nutritional supplementation

Study Results

No Results Posted as of Jan 26, 2023