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Completed

NCT Number: NCT05697900

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INDEPORTES Antioquia

Medellín, Antioquia, 050034, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. Lower-limb muscle power

    Time frame: Eight weeks

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

  2. Neuromuscular strength

    Time frame: 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

    Time frame: Eight weeks

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

Secondary outcomes

  1. Body composition

    Time frame: Eight weeks

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

Sponsors and collaborators

Lead sponsor

Dynamical Business and Science Society - DBSS International SAS

Network

Collaborators

  • CES University
  • INDEPORTES Antioquia

Registry information

Official study title

Creatine Monohydrate Versus Creatine Hydrochloride on Strength and Body Composition in Elite Team-Sport Athletes: A Three-arm Placebo-controlled Randomized Clinical Trial

Acronym: CrM_CrHCl

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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