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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Lifestyle
• Intervention / Treatment: Dietary supplement: Creatine Monohydrate; Dietary supplement: Creatine Hydrochloride; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050034
      • INDEPORTES Antioquia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dynamical Business and Science Society - DBSS International SAS
• Collaborators: CES University; INDEPORTES Antioquia
• Investigators: Study Director: Andres Rojas-Jaramillo, PhD, INDEPORTES Antioquia; Study Chair: Diego A Bonilla, PhD, DBSS International SAS

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: December 31, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Body Composition; Strength; Athletic performance; Creatine; Nutritional supplementation
• Other Study ID Numbers: Acta161_N°994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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