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

NCT05697900 | Completed DMC

• 1 other identifier: Acta161_N°994
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Keywords

Creatine; Strength; Body Composition; Athletic performance; Nutritional supplementation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Body composition

  Eight weeks

Study Arms (3)

Creatine monohydrate

ACTIVE COMPARATOR

5 g of creatine monohydrate per day for eight weeks

Dietary Supplement: Creatine Monohydrate

Creatine hydrochloride

EXPERIMENTAL

5 g of creatine hydrochloride per day for eight weeks

Dietary Supplement: Creatine Hydrochloride

Placebo

PLACEBO COMPARATOR

5 g of maltodextrin per day for eight weeks

Dietary Supplement: Placebo

Interventions

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).

Creatine monohydrate

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).

Placebo

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).

Creatine hydrochloride

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

INDEPORTES Antioquia

Medellín, Antioquia, 050034, Colombia

Location

Related Publications (3)

• 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.

  PMID: 35268011 BACKGROUND

• 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.

  PMID: 33918657 BACKGROUND

• 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.

  PMID: 31012939 BACKGROUND

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Andres Rojas-Jaramillo, PhD

  INDEPORTES Antioquia

  STUDY DIRECTOR

• Diego A Bonilla, PhD

  DBSS International SAS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 26, 2023
• Study Start: June 1, 2021
• Primary Completion: February 15, 2022
• Study Completion: August 22, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)