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

NCT ID: NCT06991426

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-10-31

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.

Conditions

Copd; Athletes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

CreaSafe® creatine

Group Type: EXPERIMENTAL

CreaSafe® creatine

Intervention Type: 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 Group Athletes

Group Type: PLACEBO_COMPARATOR

Placebo 0.03 g/kg/day

Intervention Type: 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.)

CreaSafe® creatine COPD

Group Type: EXPERIMENTAL

CreaSafe® creatine

Intervention Type: 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 Group COPD

Group Type: PLACEBO_COMPARATOR

Placebo 0.03 g/kg/day

Intervention Type: 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.)

Interventions

CreaSafe® 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.)

Intervention Type: DIETARY_SUPPLEMENT

Placebo 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.)

Intervention Type: COMBINATION_PRODUCT

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo de Paula Vieira

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Evangelical University of Goiás

Anápolis, Goiás, Brazil

Countries

Brazil

Central Contacts

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

Role: CONTACT

luis.oliveira@unievangelica.edu.br

(62)3310-6736

Facility Contacts

Luis Oliveira PPGMHR Coordinator

Role: primary

oliveira.lvf@gmail.com

References

Kreider RB, Stout JR. Creatine in Health and Disease. Nutrients. 2021 Jan 29;13(2):447. doi: 10.3390/nu13020447.

Reference Type: BACKGROUND

PMID: 33572884 (View on PubMed)

Other Identifiers

2012/15165-2

Identifier Type: -

Identifier Source: org_study_id