- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jingzhi Zhang
- Phone Number: +86 16677137704
- Email: 170787717@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Placebo Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Soreness Assessed by Visual Analog Scale (VAS)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Range of Motion (AROM) of the Knee
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GXNU20260903003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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