- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07662954
Effects of Magnesium and Spinning Training on Echocardiographic, Inflammatory, and Aerobic Outcomes
Effects of Magnesium Supplementation and Spinning Training on Cardiac Function, Oxidative Stress, Inflammation, and Aerobic Capacity
Regular aerobic exercise may improve cardiorespiratory fitness while modulating systemic inflammation and oxidative stress. Spinning, as a structured indoor cycling modality, provides a practical aerobic exercise model with adjustable intensity and duration, but its effects on redox balance, inflammatory status, aerobic capacity, and cardiac functional parameters may vary according to individual recovery and nutritional status. Magnesium is an essential micronutrient involved in energy metabolism, muscle contraction-relaxation, ion regulation, and inflammatory and oxidative pathways; therefore, magnesium use may be relevant to exercise adaptation and recovery.
This study aims to evaluate the associations of magnesium use and spinning training with oxidative stress, inflammation, aerobic capacity, and cardiac parameters. In this context, biochemical markers related to oxidative/antioxidant status and inflammation, aerobic performance indicators, and echocardiographic cardiac function parameters will be assessed together. The study is expected to provide real-world evidence on whether magnesium use in individuals participating in spinning training is associated with more favorable redox, inflammatory, aerobic, and cardiac profiles.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Karaman, Turecko (Türkiye), 70100
- Karamanoğlu Mehmetbey University, Faculty of Sport Sciences
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Self-identified male participants
- Aged 18 to 30 years
- Physically active individuals
- Participants who are eligible to participate in a structured spinning training program
- Participants with available baseline and follow-up assessments for biochemical, aerobic capacity, and cardiac function parameters
Exclusion Criteria:
- Presence of any chronic systemic disease
- Acute infection during the study period
- Regular use of anti-inflammatory or antioxidant medications
- Use of antioxidant or ergogenic supplements other than magnesium
- Any cardiovascular, musculoskeletal, or neurological condition that may limit participation in spinning training
- Missing baseline or follow-up outcome data
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: Control group
Participants in this arm will not receive any exercise training, magnesium supplementation, or placebo intervention during the study period.
They will continue their usual daily routines and will undergo the same baseline and follow-up assessments as the intervention groups.
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Aktivní komparátor: Spinning Training Group
Participants in this arm will participate in a structured spinning training program during the study period.
No magnesium supplementation or placebo will be administered.
Baseline and follow-up assessments will include oxidative stress, inflammatory, aerobic capacity, and cardiac function parameters.
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Participants will participate in a structured spinning training program during the study period.
The program will consist of supervised indoor cycling sessions performed at a planned frequency, duration, and intensity.
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Experimentální: Spinning + Magnesium Group
Participants in this arm will participate in a structured spinning training program and receive magnesium supplementation during the study period.
Baseline and follow-up assessments will include oxidative stress, inflammatory, aerobic capacity, and cardiac function parameters.
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Participants will participate in a structured spinning training program during the study period.
The program will consist of supervised indoor cycling sessions performed at a planned frequency, duration, and intensity.
Participants will receive oral magnesium supplementation during the study period in addition to the structured spinning training program.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Maximal Oxygen Uptake (VO₂max)
Časové okno: Baseline and 6 weeks
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Maximal oxygen uptake (VO₂max, mL/kg/min) will be assessed using a graded exercise test.
The change in VO₂max from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Serum Magnesium Concentration
Časové okno: Baseline and 6 weeks
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Serum magnesium concentration (mg/dL) will be measured using standard laboratory methods.
The change in serum magnesium levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Total Antioxidant Status (TAS)
Časové okno: Baseline and 6 weeks
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Serum total antioxidant status (TAS, mmol Trolox equivalent/L) will be measured using commercially available assay kits.
The change in TAS from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Total Oxidant Status (TOS)
Časové okno: Baseline and 6 weeks
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Serum total oxidant status (TOS, μmol H₂O₂ equivalent/L) will be measured using commercially available assay kits.
The change in TOS from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Paraoxonase-1 Activity (PON1)
Časové okno: Baseline and 6 weeks
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Serum paraoxonase-1 (PON1, U/L) activity will be determined using spectrophotometric methods.
The change in PON1 activity from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Arylesterase Activity (ARE)
Časové okno: Baseline and 6 weeks
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Serum arylesterase (ARE, kU/L) activity will be determined using spectrophotometric methods.
The change in ARE activity from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Časové okno: Baseline and 6 weeks
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Serum high-sensitivity C-reactive protein (hs-CRP, mg/L) concentration will be measured using standard laboratory methods.
The change in hs-CRP levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Interleukin-6 (IL-6)
Časové okno: Baseline and 6 weeks
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Serum interleukin-6 (IL-6, pg/mL) concentration will be measured using enzyme-linked immunosorbent assay methods.
The change in IL-6 levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Tumor Necrosis Factor-Alpha (TNF-α)
Časové okno: Baseline and 6 weeks
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Serum tumor necrosis factor-alpha (TNF-α, pg/mL) concentration will be measured using enzyme-linked immunosorbent assay methods.
The change in TNF-α levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Serum Potassium Concentration
Časové okno: Baseline and 6 weeks
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Serum potassium concentration (mmol/L) will be measured using standard biochemical methods.
The change in serum potassium levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Serum Calcium Concentration
Časové okno: Baseline and 6 weeks
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Serum calcium concentration (mg/dL) will be measured using standard biochemical methods.
The change in serum calcium levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP)
Časové okno: Baseline and 6 weeks
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Serum N-terminal pro-B-type natriuretic peptide (NT-proBNP, pg/mL) concentration will be measured using immunoassay methods.
The change in NT-proBNP levels from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Change in Left Ventricular Ejection Fraction (LVEF)
Časové okno: Baseline and 6 weeks
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Left ventricular ejection fraction (LVEF, %) will be assessed by transthoracic echocardiography.
The change in LVEF from baseline to 6 weeks will be evaluated.
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Baseline and 6 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Şemsi Gül Yılmaz Kocaman, PhD, Karamanoğlu Mehmetbey University
Publikace a užitečné odkazy
Obecné publikace
- Chavarrias M, Carlos-Vivas J, Collado-Mateo D, Perez-Gomez J. Health Benefits of Indoor Cycling: A Systematic Review. Medicina (Kaunas). 2019 Aug 8;55(8):452. doi: 10.3390/medicina55080452.
- Tarsitano MG, Quinzi F, Folino K, Greco F, Oranges FP, Cerulli C, Emerenziani GP. Effects of magnesium supplementation on muscle soreness in different type of physical activities: a systematic review. J Transl Med. 2024 Jul 5;22(1):629. doi: 10.1186/s12967-024-05434-x.
- Sireno L, Dimauro I, Caporossi D. Reactive oxygen species in exercise biology: from adaptive stress response to cell signaling and beyond. Free Radic Biol Med. 2026 Mar 1;245:447-462. doi: 10.1016/j.freeradbiomed.2025.12.044. Epub 2026 Jan 2. No abstract available.
- Reno AM, Green M, Killen LG, O'Neal EK, Pritchett K, Hanson Z. Effects of Magnesium Supplementation on Muscle Soreness and Performance. J Strength Cond Res. 2022 Aug 1;36(8):2198-2203. doi: 10.1519/JSC.0000000000003827. Epub 2020 Oct 1.
- Feng W, Wang Y, Gu X, Yu D, Liu Z. Exercise as a modulator of systemic inflammation and oxidative stress biomarkers across clinical and healthy populations: an umbrella meta-analysis. BMC Sports Sci Med Rehabil. 2025 Nov 28;17(1):360. doi: 10.1186/s13102-025-01327-8.
- Dominguez LJ, Veronese N, Ragusa FS, Baio SM, Sgro F, Russo A, Battaglia G, Bianco A, Barbagallo M. The Importance of Vitamin D and Magnesium in Athletes. Nutrients. 2025 May 13;17(10):1655. doi: 10.3390/nu17101655.
- Battista RA, Foster C, Andrew J, Wright G, Lucia A, Porcari JP. Physiologic responses during indoor cycling. J Strength Cond Res. 2008 Jul;22(4):1236-41. doi: 10.1519/JSC.0b013e318173dbc4.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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