- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Karaman, Törökország (Türkiye), 70100
- Karamanoğlu Mehmetbey University, Faculty of Sport Sciences
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Nincs beavatkozás: 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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Aktív összehasonlító: 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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Kísérleti: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Change in Maximal Oxygen Uptake (VO₂max)
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Total Antioxidant Status (TAS)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Şemsi Gül Yılmaz Kocaman, PhD, Karamanoğlu Mehmetbey University
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 02-2026/29
Terv az egyéni résztvevői adatokhoz (IPD)
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IPD terv leírása
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