- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07785986
Curcumin Versus Ibuprofen for Exercise-Induced Muscle Damage in Physically Active Women (CURACTIVE)
Comparative Efficacy of Oral Curcumin Supplementation Versus Ibuprofen on Exercise-Induced Muscle Damage, Inflammation, Oxidative Stress, and Sports Performance in Physically Active Women: A Randomized Double-Blind Placebo-Controlled Trial
xercise-induced muscle damage (EIMD) is a common consequence of unaccustomed or high-intensity exercise and is characterized by muscle soreness, impaired physical performance, inflammation, oxidative stress, and increased circulating biomarkers of muscle damage. Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are frequently used to alleviate these symptoms, although their repeated use may be associated with adverse effects. Curcumin, a natural polyphenol with antioxidant and anti-inflammatory properties, has emerged as a potential nutritional strategy to support post-exercise recovery.
This randomized, double-blind, placebo-controlled trial aims to compare the effects of oral curcumin supplementation and ibuprofen administration on exercise-induced muscle damage in physically active women. The study evaluates clinical outcomes, physical performance, biomarkers of muscle damage, inflammation, oxidative stress, and other health-related biomarkers to determine whether curcumin may represent a safe and effective nutritional alternative for promoting recovery after eccentric exercise.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Exercise-induced muscle damage (EIMD) following eccentric exercise is characterized by structural disruption of skeletal muscle fibers accompanied by transient inflammation, oxidative stress, delayed-onset muscle soreness, and impaired physical performance. Although these responses are considered part of the normal adaptive process, excessive muscle damage may delay recovery and impair subsequent training or competition.
Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used by athletes to reduce post-exercise pain and inflammation. However, repeated NSAID use has been associated with gastrointestinal, renal, and cardiovascular adverse effects, highlighting the need for safe nutritional alternatives capable of supporting recovery without interfering with physiological adaptation.
Curcumin, the principal bioactive polyphenol derived from Curcuma longa, exhibits antioxidant, anti-inflammatory, and cytoprotective properties through modulation of multiple molecular pathways involved in redox homeostasis and inflammatory signaling. Experimental and clinical studies suggest that curcumin may attenuate exercise-induced muscle damage by reducing oxidative stress, inflammatory responses, and muscle soreness, although evidence remains inconsistent and direct comparisons with NSAIDs are scarce.
The objective of this randomized, double-blind, placebo-controlled trial is to compare the efficacy of oral curcumin supplementation with ibuprofen and placebo in physically active women following eccentric exercise. The study evaluates clinical recovery, physical performance, biomarkers of muscle damage, inflammatory and oxidative stress biomarkers, and additional health-related biomarkers in order to characterize the physiological effects of curcumin supplementation and determine its potential role as a nutritional strategy for exercise recovery.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Soria, Spanyolország, 42004
- University Campus of Soria
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
Healthy physically active women. Age within the predefined study range. Regular participation in physical activity for at least 6 months before enrollment.
Ability to perform the eccentric exercise protocol. Written informed consent provided before participation.
Exclusion Criteria:
Current musculoskeletal injury or pain affecting exercise performance. History of cardiovascular, metabolic, neurological, renal, hepatic, or inflammatory disease.
Pregnancy or breastfeeding. Current use of anti-inflammatory drugs, antioxidant supplements, or other nutritional supplements that could interfere with study outcomes.
Known allergy or intolerance to curcumin, turmeric, ibuprofen, or study ingredients.
Smoking or excessive alcohol consumption. Participation in another clinical trial during the study period. Any condition considered by the investigators to compromise participant safety or protocol compliance.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Curcumin
Participants received oral curcumin supplementation according to the study protocol before and following the eccentric exercise protocol.
Clinical recovery, physical performance, muscle damage, inflammatory, oxidative stress, antioxidant defense, and other health-related biomarkers were evaluated during the recovery period.
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Participants received oral curcumin supplementation according to the study protocol before and after the eccentric exercise protocol.
Curcumin was administered at the predefined dose and duration specified in the protocol.
The intervention aimed to evaluate its effects on exercise-induced muscle damage, inflammation, oxidative stress, antioxidant defense, physical performance, and recovery in physically active women.
Más nevek:
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Aktív összehasonlító: Ibuprofen
articipants received oral ibuprofen according to the study protocol before and following the eccentric exercise protocol.
Clinical recovery, physical performance, muscle damage, inflammatory, oxidative stress, antioxidant defense, and other health-related biomarkers were evaluated during the recovery period.
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Participants received oral ibuprofen according to the study protocol before and after the eccentric exercise protocol.
Ibuprofen was administered at the predefined dose and duration specified in the protocol and served as the active comparator for evaluating recovery following exercise-induced muscle damage.
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Placebo Comparator: Placebo
Participants received placebo capsules identical in appearance to the active interventions according to the study protocol before and following the eccentric exercise protocol.
Clinical recovery, physical performance, muscle damage, inflammatory, oxidative stress, antioxidant defense, and other health-related biomarkers were evaluated during the recovery period.
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Participants received placebo capsules identical in appearance, packaging, and administration schedule to the active interventions.
The placebo contained inert ingredients and was administered according to the study protocol before and after the eccentric exercise protocol.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Exercise-induced muscle damage
Időkeret: Baseline and during the 72-hour recovery period following eccentric exercise.
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Exercise-induced muscle damage assessed using clinical outcomes and biochemical biomarkers following eccentric exercise to compare the effects of oral curcumin supplementation, ibuprofen, and placebo in physically active women.
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Baseline and during the 72-hour recovery period following eccentric exercise.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Creatine kinase (CK)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in serum creatine kinase concentration as a biomarker of exercise-induced skeletal muscle damage following eccentric exercise.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Lactate dehydrogenase (LDH)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in serum lactate dehydrogenase concentration as an indicator of muscle membrane disruption and tissue damage.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Aspartate aminotransferase (AST)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in serum aspartate aminotransferase concentration as an indirect biomarker of exercise-induced muscle tissue damage.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Alanine aminotransferase (ALT)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in serum alanine aminotransferase concentration following eccentric exercise.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Alkaline phosphatase (ALP)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in serum alkaline phosphatase concentration following eccentric exercise.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Interleukin-6 (IL-6)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in circulating interleukin-6 concentration as a biomarker of the inflammatory response to exercise-induced muscle damage.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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C-reactive protein (CRP)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in serum C-reactive protein concentration as a marker of systemic inflammation following eccentric exercise.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Malondialdehyde (MDA)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in plasma malondialdehyde concentration as a biomarker of lipid peroxidation and oxidative stress.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Superoxide dismutase (SOD)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in superoxide dismutase activity as an indicator of endogenous antioxidant defense.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Catalase (CAT)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in catalase activity as a marker of antioxidant defense following eccentric exercise.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Delayed-onset muscle soreness (DOMS)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in perceived muscle soreness assessed using a validated visual analogue scale following eccentric exercise.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Countermovement jump (CMJ)
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in countermovement jump performance as a measure of lower-limb neuromuscular function and exercise recovery.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Thigh circumference
Időkeret: Baseline and during the 48-hour recovery period following eccentric exercise.
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Changes in thigh circumference as an indirect indicator of exercise-induced muscle swelling.
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Baseline and during the 48-hour recovery period following eccentric exercise.
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
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
Kulcsszavak
További vonatkozó MeSH feltételek
- Patológiás folyamatok
- Kóros állapotok, jelek és tünetek
- Gyulladás
- Szerves vegyi anyagok
- Szénhidrogének, aciklusos
- Szénhidrogének
- Szénhidrogének, ciklikus
- Karbonsavak
- Szénhidrogének, aromás
- Diarilhepanoidok
- Heptán
- Alkánok
- Katecholok
- Fenolok
- Benzolszármazékok
- Savak, karbociklusos
- Fenilpropionátok
- Kurkumin
- Ibuprofen
- kurkuma kivonat
Egyéb vizsgálati azonosító számok
- DFL-CURC-2025-01
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
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