Athletes, Copd
Conditions
Keywords
creatine, supplementation, kidneys, heart, lungs, hematology
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCreaSafe® creatine
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.)
COMBINATION_PRODUCTPlacebo 0.03 g/kg/day
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.)
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Inflammatory Cytokine Concentrations | 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
| Measure | Time frame | Description |
|---|---|---|
| Urinalysis Parameters | 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. |
| Urinary Cytokine Concentrations | 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. |
| Renal Safety Assessed by Serum and Urinary Biomarkers | 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. |
| Muscle Strength Assessed by Dynamometry | 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. |
| Plasma Markers of Muscle Damage and Recovery | 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. |
| Lean Body Mass Assessed by Multifrequency Bioelectrical Impedance | 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. |
Countries
Brazil
Contacts
Primary ContactLuis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov
Outcome results
None listed