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

Healthy Lifestyle Clinical Trial

— CrM_CrHCl  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697900
• Other study ID #: Acta161_N°994
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: January 2023
• Source: Dynamical Business and Science Society - DBSS International SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 22, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Colombia	INDEPORTES Antioquia	Medellín	Antioquia

Sponsors (3)

Lead Sponsor	Collaborator
Dynamical Business and Science Society - DBSS International SAS	CES University, INDEPORTES Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Upper-limb muscle strength	Maximal shoulder external and internal strength will be measure with a isokinetic dynamometer.	Eight weeks
Secondary	Body composition	Body composition was measured using dual-energy x-ray absorptiometry. Fat mass and lean mass in kilograms were reported.	Eight weeks