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

NCT06991426 | Not Yet Recruiting Phase 4

• 1 other identifier: 2012/15165-2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

creatine; supplementation; kidneys; heart; lungs; hematology

Outcome Measures

Primary Outcomes (1)

• Plasma Inflammatory Cytokine Concentrations

  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.

  Baseline and after 90 days of supplementation

Secondary Outcomes (6)

• Renal Safety Assessed by Serum and Urinary Biomarkers

  Baseline and after 90 days of supplementation

• Urinalysis Parameters

  Baseline and after 90 days of supplementation

• Urinary Cytokine Concentrations

  Baseline and after 90 days of supplementation

• Lean Body Mass Assessed by Multifrequency Bioelectrical Impedance

  Baseline and after 90 days of supplementation

• Muscle Strength Assessed by Dynamometry

  Baseline and after 90 days of supplementation

Study Arms (4)

CreaSafe® creatine

EXPERIMENTAL

Dietary Supplement: CreaSafe® creatine

Placebo Group Athletes

PLACEBO COMPARATOR

Combination Product: Placebo 0.03 g/kg/day

CreaSafe® creatine COPD

EXPERIMENTAL

Dietary Supplement: CreaSafe® creatine

Placebo Group COPD

PLACEBO COMPARATOR

Combination Product: Placebo 0.03 g/kg/day

Interventions

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.)

CreaSafe® creatine; CreaSafe® creatine COPD

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.)

Placebo Group Athletes; Placebo Group COPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-athletes and individuals without a diagnosis of COPD

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Evangelical University of Goiás

Anápolis, Goiás, 75083-515, Brazil

Location

Related Publications (1)

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

  PMID: 33572884 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

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

CONTACT

(62)3310-6736; luis.oliveira@unievangelica.edu.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 28, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)