Clinical trial NCT06991426: Effects of CreaSafe® on Kidney, Muscle, and Cardiopulmonary Function in Athletes and COPD Patients
Official title: Effects of a New Creatine Formulation (CreaSafe®) on Kidney Function, Skeletal Muscles, and Cardiopulmonary Function in Athletes and Patients With COPD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Copd
Athletes
Keywords: creatine
supplementation
kidneys
heart
lungs
hematology
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Inflammatory Cytokine Concentrations
timeFrame: Baseline and after 90 days of supplementation
Secondary outcomes:
measure: Renal Safety Assessed by Serum and Urinary Biomarkers
timeFrame: Baseline and after 90 days of supplementation
measure: Urinalysis Parameters
timeFrame: Baseline and after 90 days of supplementation
measure: Urinary Cytokine Concentrations
timeFrame: Baseline and after 90 days of supplementation
measure: Lean Body Mass Assessed by Multifrequency Bioelectrical Impedance
timeFrame: Baseline and after 90 days of supplementation
measure: Muscle Strength Assessed by Dynamometry
timeFrame: Baseline and after 90 days of supplementation
measure: Plasma Markers of Muscle Damage and Recovery
timeFrame: Baseline and after 90 days of supplementation
Other outcomes:
Locations:
city: Anápolis
country: Brazil
facility: Evangelical University of Goiás
state: GO
Study officials:
References:
citation: Kreider RB, Stout JR. Creatine in Health and Disease. Nutrients. 2021 Jan 29;13(2):447. doi: 10.3390/nu13020447.