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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка 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.)
• Комбинированный продукт 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.)

Первичные конечные точки

• Plasma Inflammatory Cytokine Concentrations [Срок оценки: Baseline and after 90 days of supplementation]

Вторичные конечные точки (6)

• Renal Safety Assessed by Serum and Urinary Biomarkers [Срок оценки: Baseline and after 90 days of supplementation]
• Urinalysis Parameters [Срок оценки: Baseline and after 90 days of supplementation]
• Urinary Cytokine Concentrations [Срок оценки: Baseline and after 90 days of supplementation]
• Lean Body Mass Assessed by Multifrequency Bioelectrical Impedance [Срок оценки: Baseline and after 90 days of supplementation]
• Muscle Strength Assessed by Dynamometry [Срок оценки: Baseline and after 90 days of supplementation]
• Plasma Markers of Muscle Damage and Recovery [Срок оценки: Baseline and after 90 days of supplementation]

Критерии участия

Критерии включения

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

Критерии исключения

• Non-athletes and individuals without a diagnosis of COPD

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 1 центр

• Evangelical University of Goiás — Anápolis

Публикации

• Kreider RB, Stout JR. Creatine in Health and Disease. Nutrients. 2021 Jan 29;13(2):447. doi: 10.3390/nu13020447. PMID 33572884

Идентификаторы

NCT: NCT06991426 · 2012/15165-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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