- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07836985
Mogrosides for Delayed-Onset Muscle Soreness
Effects of Mogroside Intervention on the Levels of Delayed-Onset Muscle Soreness-Related Indicators
This study will examine whether taking mogrosides, natural compounds found in monk fruit, affects delayed-onset muscle soreness (DOMS) and related markers of muscle damage, inflammation, oxidative stress, and muscle function after strenuous exercise. The study will also explore whether changes in the body's antioxidant capacity are related to changes in DOMS-related measures.
The study plans to enroll 16 healthy young male students. Participants will be randomly assigned to a control group (n=8) or an experimental group (n=8). The control group will receive a placebo, and the experimental group will receive mogrosides. Participants will take their assigned product by mouth for 27 days, perform a standardized frog-jump training session, and then continue taking the assigned product for 3 more days.
Researchers will measure subjective muscle soreness using a visual analog scale (VAS) at baseline before supplementation, before exercise, immediately after exercise, and 24, 48, and 72 hours after exercise. At these same time points, they will also measure serum creatine kinase (CK) and creatine kinase isoenzyme MM (CK-MM) activity, total antioxidant capacity (T-AOC), malondialdehyde (MDA), plasma interleukin-6 (IL-6), thigh circumference at the junction of the middle and lower thirds of the thigh, maximal isometric strength for lifting the thigh, and active range of motion (AROM) of the knee.
The study will assess the effects of mogroside supplementation on DOMS severity and on changes in muscle damage, inflammation, oxidative stress, and muscle function. It will also explore whether improved antioxidant capacity is related to changes in DOMS-related indicators. This study is not yet recruiting participants.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jingzhi Zhang
- Numer telefonu: +86 16677137704
- E-mail: 170787717@qq.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Male, aged 20 to 23 years.
- Healthy, with no history of major diseases or severe injuries.
- Physical fitness level comparable to that of an ordinary physical education/sports student.
- No training or competition obligations during the study period.
- Provides informed consent for the study protocol.
Exclusion Criteria:
- History of musculoskeletal injury within the past 2 months.
- Use of anti-inflammatory drugs or steroid medications within the past 1 month.
- Use of antioxidant medications such as vitamin E or vitamin C within the past 1 month.
- Use of any other medications within the past 2 weeks.
- Participation in strenuous exercise within the past 10 days.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Mogroside
Eight participants will be randomly assigned to the experimental arm. They will receive oral mogroside (batch no. YTC19011823; purity >95%; mogroside V 50.56%), prepared as a 3% (g/mL) solution in warm drinking water, at 6 g per dose twice daily (12 g/day) in the morning and evening for 27 days. After 27 days, participants will perform a standardized frog-jump exercise to induce delayed-onset muscle soreness (DOMS): 10 sets of 25 consecutive jumps, with 2 minutes of rest between sets, after a 10-minute warm-up; total session approximately 34-35 minutes. They will continue the same mogroside intervention for 3 additional days after exercise. All participants will complete the same scheduled assessments. The study will be double-blind. |
Eight participants will be randomly assigned to the experimental arm. They will receive oral mogroside (batch no. YTC19011823; purity >95%; mogroside V 50.56%), prepared as a 3% (g/mL) solution in warm drinking water, at 6 g per dose twice daily (12 g/day) in the morning and evening for 27 days. After 27 days, participants will perform a standardized frog-jump exercise to induce delayed-onset muscle soreness (DOMS): 10 sets of 25 consecutive jumps, with 2 minutes of rest between sets, after a 10-minute warm-up; total session approximately 34-35 minutes. They will continue the same mogroside intervention for 3 additional days after exercise. All participants will complete the same scheduled assessments. The study will be double-blind. |
|
Komparator placebo: Placebo
Eight participants will be randomly assigned to the control arm. They will receive an equal volume of warm drinking water as placebo twice daily in the morning and evening for 27 days. After 27 days, participants will perform the same standardized frog-jump exercise to induce delayed-onset muscle soreness (DOMS): 10 sets of 25 consecutive jumps, with 2 minutes of rest between sets, after a 10-minute warm-up; total session approximately 34-35 minutes. They will continue the same placebo intervention for 3 additional days after exercise. All participants will complete the same scheduled assessments. The study will be double-blind. |
Eight participants will be randomly assigned to the control arm. They will receive an equal volume of warm drinking water as placebo twice daily in the morning and evening for 27 days. After 27 days, participants will perform the same standardized frog-jump exercise to induce delayed-onset muscle soreness (DOMS): 10 sets of 25 consecutive jumps, with 2 minutes of rest between sets, after a 10-minute warm-up; total session approximately 34-35 minutes. They will continue the same placebo intervention for 3 additional days after exercise. All participants will complete the same scheduled assessments. The study will be double-blind. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Muscle Soreness Assessed by Visual Analog Scale (VAS)
Ramy czasowe: From enrollment to the end of treatment at 30 days
|
Subjective muscle soreness will be assessed at six time points: before the first dose of study product, before exercise, immediately after exercise, and 24, 48, and 72 hours after exercise. A 10-cm VAS ruler will be used. The side facing the participant is marked 0 at one end ("no pain") and 10 at the other ("worst imaginable pain"). Participants will move a cursor to indicate their current level of muscle soreness. The distance from the "no pain" end to the mark will be recorded as the pain score in centimeters. Higher scores indicate greater muscle soreness. |
From enrollment to the end of treatment at 30 days
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Active Range of Motion (AROM) of the Knee
Ramy czasowe: From enrollment to the end of treatment at 30 days
|
Bilateral active knee range of motion will be measured with a joint angle goniometer at six time points: before the first dose, before exercise, immediately after exercise, and 24, 48, and 72 hours after exercise. Participants will lie prone with both lower limbs extended, together, and relaxed. The goniometer axis will be placed at the lateral femoral condyle, the fixed arm along the middle of the femur, and the moving arm along the fibula. Participants will actively flex the lower leg as much as possible. The arc from the starting position to the final position of the lower leg will be recorded in degrees. |
From enrollment to the end of treatment at 30 days
|
|
Maximal Isometric Muscle Force for Lifting the Thigh
Ramy czasowe: From enrollment to the end of treatment at 30 days
|
Bilateral maximal isometric muscle force will be measured with a MicroFET2 handheld dynamometer at six time points: before the first dose, before exercise, immediately after exercise, and 24, 48, and 72 hours after exercise. Participants will sit on the examination bed with arms at their sides, legs relaxed, and lower legs hanging vertically. The tester will place the dynamometer over the distal quadriceps on the front of the thigh. Participants will push the thigh upward against the tester and maintain the contraction for 8 seconds. The test will be repeated 5 times, and the maximum value will be recorded. |
From enrollment to the end of treatment at 30 days
|
|
Thigh Circumference at the Junction of the Middle and Lower Thirds
Ramy czasowe: From enrollment to the end of treatment at 30 days
|
Bilateral thigh circumference will be measured with a soft tape measure at six time points: before the first dose, before exercise, immediately after exercise, and 24, 48, and 72 hours after exercise. Participants will lie prone on the examination bed. The circumference will be measured at the junction of the middle and lower thirds of the line between the greater trochanter of the femur and the lateral condyle. The measurement point will be marked after the first measurement to ensure the same location is used at later time points. Results will be recorded in centimeters. |
From enrollment to the end of treatment at 30 days
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- GXNU20260903003
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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