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

NCT ID: NCT05697900

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-08-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a double-blinded placebo-controlled repeated-measures randomized clinical trial in elite team-sport athletes with three arms in parallel.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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).

Study Groups

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Creatine monohydrate

5 g of creatine monohydrate per day for eight weeks

Group Type ACTIVE_COMPARATOR

Creatine Monohydrate

Intervention Type 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 hydrochloride

5 g of creatine hydrochloride per day for eight weeks

Group Type EXPERIMENTAL

Creatine Hydrochloride

Intervention Type 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).

Placebo

5 g of maltodextrin per day for eight weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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INDEPORTES Antioquia

UNKNOWN

Sponsor Role collaborator

CES University

OTHER

Sponsor Role collaborator

Dynamical Business and Science Society - DBSS International SAS

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andres Rojas-Jaramillo, PhD

Role: STUDY_DIRECTOR

INDEPORTES Antioquia

Diego A Bonilla, PhD

Role: STUDY_CHAIR

DBSS International SAS

Locations

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INDEPORTES Antioquia

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type BACKGROUND
PMID: 35268011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33918657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31012939 (View on PubMed)

Other Identifiers

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Acta161_N°994

Identifier Type: -

Identifier Source: org_study_id

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