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NCT Number: NCT06991426

Effects of CreaSafe® on Kidney, Muscle, and Cardiopulmonary Function in Athletes and COPD Patients

Creatine supplementation (CS) offers numerous health benefits, with no proven side effects reported to date. CS positively impacts all organs and systems of the body. However, there is an ongoing effort among several creatine-producing companies to develop increasingly pure creatine formulations that generate fewer renal metabolites. Therefore, this study aims to evaluate the effects of a new creatine formulation, CreaSafe®, synthesized by the Chinese company Wenda®, on kidney function in athletes and patients with chronic obstructive pulmonary disease (COPD), as well as its effects on skeletal muscles and cardiopulmonary function. Regarding the athletes (Study 1), the sample will consist of 80 healthy athletes (40 strength-training athletes and 40 middle- and long-distance runners). Among each group of 40 athletes, 20 will receive CreaSafe® creatine (0.03 g/kg/day), while the other 20 will receive a placebo (microcrystalline cellulose; 0.03 g/kg/day), for 90 days, orally administered in water in the morning (between 7:00 a.m. and 9:00 a.m.). For the COPD patients (Study 2), 60 patients with severe and/or very severe COPD will be recruited. Of these, 30 will receive CreaSafe® creatine (0.03 g/kg/day), while the other 30 will receive placebo (microcrystalline cellulose; 0.03 g/kg/day), also administered orally in water for 90 days in the morning (between 7:00 a.m. and 9:00 a.m.). The supplementation period for both studies will last 90 days, with assessments performed at baseline and after 90 days. Kidney function will be evaluated through urinalysis (Urine Type I), the balance of pro- vs. anti-inflammatory cytokines, and levels of urea, creatine kinase (CK), and creatinine. Body composition will be assessed using octopolar and multifrequency bioimpedance, along with circumference measurements of body segments. Muscle strength of different muscle groups will be assessed using the E-lastic dynamometer. Biomarkers of skeletal muscle degradation and recovery will also be measured in plasma, including CK, lactate dehydrogenase (LDH), urea, myoglobin, and the levels of IL-1beta, IL-4, IL-6, IL-10, TNF-alpha, Atrogin-1, MuRF-1, and GDF-8 (myostatin). Whole blood analysis (erythrocytes, leukocytes, and platelets) will be performed using a fully automated blood analyzer (Sysmex XS 800i). Pulmonary function will be assessed through pre- and post-bronchodilator spirometry, as well as maximal inspiratory (PIMax) and expiratory (PEMax) pressures using a manovacuometer. Cardiovascular function will be evaluated using electrocardiography (ECG) and cardiovascular hemodynamics assessed by impedance cardiography (PhysioFlow). GraphPad Prism 5.0 software will be used for statistical analyses and graph generation. Paired Student's t-tests will be used to compare pre- and post-intervention values within each group, and unpaired Student's t-tests will be used to compare deltas between the CreaSafe® and placebo groups. Statistical significance will be considered at p ≤ 0.05.

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Key information

Conditions

COPD Athletes Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Evangelical University of Goiás

Anápolis, Goiás, 75083-515, Brazil

Location contact

Luis Oliveira PPGMHR Coordinator

CONTACT

[email protected]

Rodolfo de Paula Vieira

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • resistance-trained athletes middle- and long-distance runners severe and/or very severe COPD

Exclusion criteria

  • Non-athletes and individuals without a diagnosis of COPD

Treatment and study plan

CreaSafe® creatine

Dietary Supplement

Will receive CreaSafe® creatine (0.03 g/kg/day) for 90 days, orally administered diluted in water, every morning (between 7:00 and 9:00 a.m.)

Placebo 0.03 g/kg/day

Combination Product

will receive a placebo (microcrystalline cellulose; 0.03 g/kg/day) for 90 days, orally administered diluted in water, every morning (between 7:00 and 9:00 a.m.)

Primary outcomes

  1. Plasma Inflammatory Cytokine Concentrations

    Time frame: Baseline and after 90 days of supplementation

    Plasma inflammatory cytokines (IL-1β, IL-4, IL-6, IL-10, TNF-α) will be measured using DuoSet® ELISA kits (R&D Systems, USA). Blood samples will be collected at baseline and after 90 days of supplementation. Unit of Measure: pg/mL.

    Mean and standard deviation within each group; pre- and post-intervention comparisons.

Secondary outcomes

  1. Renal Safety Assessed by Serum and Urinary Biomarkers

    Time frame: Baseline and after 90 days of supplementation

    Renal safety will be assessed by measuring serum and urinary biomarkers using Labtest® kits (Brazil). The following biomarkers will be analyzed: serum creatinine (mg/dL), estimated glomerular filtration rate (eGFR; mL/min/1.73 m²), serum urea (mg/dL), and urinary microalbuminuria (mg/g creatinine). Samples will be collected at baseline and after 90 days of supplementation with CreaSafe®.

    Unit of Measure:

    Creatinine: mg/dL eGFR: mL/min/1.73 m² Urea: mg/dL Microalbuminuria: mg/g creatinine Data Aggregation: Mean and standard deviation within each group, with intra- and intergroup comparisons between pre- and post-intervention values.

  2. Urinalysis Parameters

    Time frame: Baseline and after 90 days of supplementation

    Urinalysis will be conducted using reagent strips to assess the following parameters: blood (positive/negative), bilirubin (mg/dL), urobilinogen (mg/dL), ketones (mg/dL), proteins (mg/dL), nitrite (positive/negative), glucose (mg/dL), leukocytes (positive/negative), ascorbic acid (mg/dL), pH, and urine specific gravity (density; g/mL). Assessments will be performed at baseline and after 90 days of supplementation.

    Data Aggregation: Descriptive analysis of the prevalence for qualitative measures; mean and standard deviation for quantitative measures, with comparisons pre- and post-intervention.

  3. Urinary Cytokine Concentrations

    Time frame: Baseline and after 90 days of supplementation

    Urinary cytokines will be measured using DuoSet® ELISA kits (R&D Systems, USA). The following cytokines will be analyzed: IL-1β, IL-1ra, IL-2, IL-6, IL-10, IFN-β, IFN-γ, and TNF-α. Samples will be collected at baseline and after 90 days of supplementation.Unit of Measure: pg/mL.

    Data Aggregation: Mean and standard deviation within each group, with intra- and intergroup comparisons between pre- and post-intervention values.

  4. Lean Body Mass Assessed by Multifrequency Bioelectrical Impedance

    Time frame: Baseline and after 90 days of supplementation

    Lean body mass will be assessed using an octopolar multifrequency bioelectrical impedance analyzer. Measurements will be performed at baseline and after 90 days of supplementation with CreaSafe®. Unit of Measure: kg Data Aggregation: Mean and standard deviation within each group; pre- and post-intervention comparisons.

  5. Muscle Strength Assessed by Dynamometry

    Time frame: Baseline and after 90 days of supplementation

    Muscle strength in major muscle groups (biceps, triceps, chest, calf, waist, hips, thighs) will be assessed using an E-lastic dynamometer (AVS Projetos®). Measurements will be conducted at baseline and after 90 days of supplementation. Unit of Measure: kgf (kilogram-force) Data Aggregation: Mean and standard deviation within each group; pre- and post-intervention comparisons.

  6. Plasma Markers of Muscle Damage and Recovery

    Time frame: Baseline and after 90 days of supplementation

    Plasma concentrations of creatine kinase (CK), lactate dehydrogenase (LDH), urea, and myoglobin will be measured using standard spectrophotometric biochemical assays. Blood samples will be collected at baseline and after 90 days of supplementation.

    Unit of Measure:

    CK, LDH, urea: U/L Myoglobin: ng/mL Data Aggregation: Mean and standard deviation within each group; pre- and post-intervention comparisons.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov

CONTACT

[email protected]

(62)3310-6736

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effects of a New Creatine Formulation (CreaSafe®) on Kidney Function, Skeletal Muscles, and Cardiopulmonary Function in Athletes and Patients With COPD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

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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