Muscle DamageCOR-FASTNCT07726979
The Combined Effects of Cordyceps and Fartlek Training on Muscle Recovery and Bone Health in Soccer Players
A study testing Fartlek Training Program and Cordyceps sinensis Supplementation in people with Muscle Damage and Athletic Performance, run by Surabaya State University at 1 site in Indonesia.
Trial summary
Purpose of the Study:This study aims to evaluate the effectiveness of combining Cordyceps supplementation and fartlek training as a recovery and performance enhancement strategy for soccer players. Muscle injuries often occur when athletes train intensely without adequate recovery. Read more about this study
- Who is it for?
- Ages 18 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Athletic Performance, Oxidative Stress
- What is being tested?
- Fartlek Training Program and Cordyceps sinensis Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 May 2024to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- Men only
- Healthy volunteers accepted
- Adult
Kriteria Inklusi:
- Status saat ini sebagai atlet sepak bola kompetitif aktif.
- Berusia antara 18 dan 20 tahun.
- Memiliki asupan oksigen maksimal (VO2max) dasar minimal 44 mL·kg-¹·min-¹.
- Dinyatakan sehat secara fisik dan mental berdasarkan pemeriksaan medis.
- Bersedia mematuhi protokol pelatihan Fartlek dan jadwal suplementasi kapsul yang telah ditentukan.
- Memberikan persetujuan tertulis untuk berpartisipasi dalam penelitian.
Kriteria Eksklusi:
- Berusia di bawah 18 tahun.
- Terdaftar aktif di klub profesional pada saat penelitian.
- Riwayat cedera muskuloskeletal atau fisik yang mengganggu performa pelatihan maksimal.
- Saat ini mengonsumsi suplemen makanan, alat bantu ergogenik, atau obat-obatan lain dalam 4 minggu sebelum pengukuran awal.
- Memiliki alergi atau hipersensitivitas terhadap Cordyceps sinensis atau komponen kapsul apa pun.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Football Laboratory, Faculty of Sports Science and Health
Surabaya, Jawa Timur - East Java, 60213
About this study
Official title: An Exploration of the Combined Effects of Cordyceps Supplementation and Fartlek Training on Inflammatory, Oxidative Stress, Muscle Damage, and Bone Metabolism Biomarkers (IL-6, IL-10, SOD, MDA, CK, BaLP, OST) in Soccer Players
Purpose of the Study:This study aims to evaluate the effectiveness of combining Cordyceps supplementation and fartlek training as a recovery and performance enhancement strategy for soccer players. Muscle injuries often occur when athletes train intensely without adequate recovery. Cordyceps contains bioactive compounds with anti-inflammatory and antioxidant properties, while Fartlek training is designed to improve cardiovascular endurance. This study analyses how this combination affects both the physiological recovery and physical performance of soccer players. Research Question: Does the combination of Cordyceps supplementation and Fartlek training effectively reduce muscle damage, decrease oxidative stress, promote bone metabolism, and improve cardiorespiratory fitness in soccer players? Methodology and Biomarkers: To answer this question, the study evaluates specific physiological indicators from the participants' blood samples and physical tests. Muscle damage and recovery are assessed through creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10). Oxidative stress levels are monitored using superoxide dismutase (SOD) and malondialdehyde (MDA). Bone metabolism and health are measured via bone alkaline phosphatase (BALP) and osteocalcin (OST). Additionally, improvements in the athletes' aerobic capacity and overall physical performance are determined by measuring their maximal oxygen consumption (VO₂max).
Read the detailed description
High-intensity athletic training, such as soccer, places rigorous physiological stress on the human body, frequently leading to exercise-induced muscle damage (EIMD), systemic inflammation, and elevated oxidative stress. When recovery periods are insufficient, these factors culminate in persistent fatigue, compromised bone metabolism, and an increased risk of injury. This study investigates a novel, multifaceted recovery and conditioning paradigm by combining the adaptogenic properties of Cordyceps supplementation with the cardiovascular demands of Fartlek training. Mechanistic Framework of Cordyceps and Fartlek TrainingCordyceps contains potent bioactive compounds, including cordycepin, polysaccharides, adenosine, and mannitol. These constituents exhibit strong anti-inflammatory, antioxidant, and anti-apoptotic properties at the cellular level. By counteracting the excessive accumulation of free radicals and downregulating pro-inflammatory pathways (such as NF-$\kappa$B activation), Cordyceps is hypothesised to accelerate structural muscle repair. Concurrently, Fartlek training-a form of continuous training with alternating bursts of high and low intensity-acts as a potent stimulus for cardiovascular and aerobic conditioning, driving adaptations in capillary density and mitochondrial efficiency. Physiological and Biomarker Profiles This trial utilises a comprehensive panel of serum and physical biomarkers to map the synergistic effects of the intervention: Inflammatory Response \& Muscle Damage: The study monitors the kinetics of interleukins to evaluate the shift from a pro-inflammatory state to an anti-inflammatory recovery environment. Interleukin-6 (IL-6) serves as a marker of acute metabolic and inflammatory stress, while interleukin-10 (IL-10) is analysed to track the activation of anti-inflammatory signalling. Additionally, Creatine Kinase (CK) levels are measured as a direct indicator of sarcolemmal disruption and micro-tears in muscle fibres. Oxidative Stress Regulation: To evaluate the antioxidant capacity, the trial quantifies Malondialdehyde (MDA), a primary byproduct of lipid peroxidation, against the activity of Superoxide Dismutase (SOD), an essential endogenous antioxidant enzyme responsible for neutralising superoxide radicals. Bone Metabolism and Turnover: High-impact sports alter bone remodelling. This study assesses the skeletal response to the combined protocol by tracking Bone Alkaline Phosphatase (BALP), a specific marker of osteoblastic bone formation, and Osteocalcin (OST), a non-collagenous protein essential for bone matrix mineralisation and metabolic regulation. Aerobic Power and Adaptation: Beyond biochemical markers, the ultimate physiological translation of enhanced recovery is measured via maximal oxygen consumption (VO₂max). This metric serves to evaluate whether the accelerated recovery mediated by Cordyceps allows athletes to achieve superior cardiorespiratory adaptations during Fartlek conditioning.
- Conditions
- Muscle Damage, Athletic Performance, Oxidative Stress, Inflammation, Bone Metabolism, Cardiorespiratory Fitness
- Being tested
- Fartlek Training Program, Cordyceps sinensis Supplementation, Placebo
- Keywords
- Cordyceps supplementation, Herbal adaptogens in sport, Sports recovery, Athletic performance, Fartlek, Soccer
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fartlek Training ProgramOther
The progressive fartlek programme was performed in the morning, three times weekly for four weeks, with each athlete required to reach 85% of maximal heart rate
Cordyceps sinensis SupplementationDietary supplement
The dietary supplement intervention consists of oral administration of Cordyceps sinensis extract. Participants in the experimental group (Fartlek-Cordyceps) are required to ingest a daily dosage of 500 mg Cordyceps sinensis per capsule. The dosing protocol is strictly timed to maximize absorption and recovery: one capsule is taken every night before bed, and on training days, an additional capsule is administered exactly 1 hour prior to the Fartlek session
PlaceboDietary supplement
The control intervention consists of oral administration of a placebo capsule. The placebo is completely inert and contains no active ingredients, but it is manufactured to be physically identical to the active Cordyceps sinensis supplement in size, shape, color, and taste to preserve the double-blind trial design. Participants in the Fartlek-Placebo (FP) group follow the exact same dosing schedule as the experimental group: one placebo capsule is taken every night before bed, and on designated training days, an additional capsule is ingested exactly 1 hour prior to commencing the Fartlek running session. This exact timing controls for the psychological and physiological behavioral effects of pill-taking routines. This intervention allows researchers to establish a true baseline to evaluate whether changes in muscle damage, systemic inflammation, oxidative stress, and aerobic capacity are driven by the active Cordyceps compound or by the training protocol alone.
| Study group | Role | What they receive |
|---|---|---|
| The Fartlek-Cordyceps (FC) group | Experimental | The dietary supplement intervention consists of oral administration of Cordyceps sinensis extract. Participants in the experimental group (Fartlek-Cordyceps) are required to ingest a daily dosage of 500 mg Cordyceps sinensis per capsule. The dosing protocol is strictly timed to maximize absorption and recovery: one capsule is taken every night before bed, and on training days, an additional capsule is administered exactly 1 hour prior to the Fartlek session. This supplementation runs concurrently with the physical training period. To maintain the double-blind design, capsules are identical to the placebo in appearance and taste. This targeted timing aims to protect muscle fibers from acute training stress during exercise and accelerate cellular repair overnight, ultimately acting to suppress inflammatory responses, mitigate oxidative damage, and support bone metabolism markers under high physiological loads. Receives: Other: Fartlek Training Program; Dietary Supplement: Cordyceps sinensis Supplementation |
| The Fartlek-Placebo (FP) group | Placebo comparator | Participants assigned to this comparator arm undergo a structured Fartlek training program while receiving a placebo intervention to maintain the trial's double-blind design. The physical training protocol consists of continuous running sessions with alternating intensity bursts, identical in frequency, duration, and workload to the experimental group. For the supplementation control, participants are required to orally ingest a daily placebo capsule that is visually identical to the active treatment, matched exactly for size, shape, color, and taste. The dosing schedule mimics the experimental protocol: one capsule is taken every night before bed, and on training days, one capsule is administered 1 hour prior to the Fartlek session. This arm serves to isolate the physiological adaptations of the physical training alone and controls for the placebo effect on muscle damage, inflammation, oxidative stress, bone metabolism, and VO2max. Receives: Other: Fartlek Training Program; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Serum Creatine Kinase (CK) Concentration After 4 Weeks
Serum Creatine Kinase (CK) is measured to evaluate the extent of exercise-induced muscle damage. Blood samples are analyzed using an automated biochemistry analyzer. An increase in CK levels indicates muscle fiber disruption, while lower post-exercise levels in the intervention group suggest a protective effect of the supplement. Results are reported in Units per Liter (U/L)
Measured: Baseline and Post-Intervention (Week 4)
Change from Baseline in Serum Interleukin-6 (IL-6) Levels After 4 Weeks
Serum Interleukin-6 (IL-6) is measured as a primary biomarker for acute systemic inflammatory responses and muscle-derived cytokine secretion induced by high-intensity training. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Lower change scores indicate suppressed systemic pro-inflammatory pathways. Results are reported in picograms per milliliter (pg/mL)
Measured: Baseline and Post-Intervention (Week 4)
Change from Baseline in Serum Interleukin-10 (IL-10) Levels After 4 Weeks
Serum Interleukin-10 (IL-10) is measured to evaluate the anti-inflammatory response to exercise stress. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Higher change scores or maintained levels of this cytokine indicate a well-regulated anti-inflammatory mechanism that assists in tissue repair and resolution of inflammation. Results are reported in picograms per milliliter (pg/mL).
Measured: Baseline and Post-Intervention (Week 4)
Change from Baseline in Superoxide Dismutase (SOD) Activity After 4 Weeks
Superoxide Dismutase (SOD) activity is measured to assess endogenous antioxidant enzyme defenses against oxidative stress induced by strenuous exercise. Blood samples are analyzed using a spectrophotometric assay kit. Higher change scores indicate enhanced antioxidant capacity to neutralize reactive oxygen species (ROS). Results are reported in Units per milliliter (U/mL).
Measured: Baseline and Post-Intervention (Week 4)
Change from Baseline in Serum Malondialdehyde (MDA) Levels After 4 Weeks
Serum Malondialdehyde (MDA) is measured as a key biomarker of lipid peroxidation to quantify oxidative damage to cell membranes resulting from high-intensity training. Blood samples are analyzed using the Thiobarbituric Acid Reactive Substances (TBARS) spectrophotometric assay. Lower change scores signify mitigated oxidative stress and cellular protection. Results are reported in nanomoles per milliliter (nmol/mL)
Measured: Baseline and Post-Intervention (Week 4)
Change from Baseline in Maximal Oxygen Uptake (VO2max) After 4 Weeks of Training
Maximal oxygen uptake (VO2max) is measured to evaluate improvements in cardiorespiratory fitness and aerobic capacity. Participants undergo a standardized physical fitness field test (such as the Yo-Yo Intermittent Recovery Test or a progressive shuttle run test) specific to soccer players. Higher change scores indicate superior aerobic adaptation and physiological conditioning. Results are reported in milliliters of oxygen per kilogram of body weight per minute (mL/kg/min).
Measured: Baseline and Post-Intervention (Week 4)
Secondary outcomes (2)
Change from Baseline in Bone Alkaline Phosphatase (BALP) Levels After 4 Weeks
Serum Bone Alkaline Phosphatase (BALP) is measured as a secondary biomarker to evaluate osteoblast activity and bone formation rates under high physiological loading. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. This outcome helps determine the interaction between mechanical stress from running and nutritional intervention on bone turnover. Results are reported in micrograms per liter (mcg/L)
Measured: Baseline and Post-Intervention (Week 4)
Change from Baseline in Serum Osteocalcin (OST) Concentration After 4 Weeks
Serum Osteocalcin (OST) is measured as a specific marker for bone turnover and mineralization to track skeletal adaptations to the combined training and supplementation protocol. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Balanced change scores indicate healthy bone remodeling and metabolic stability during training. Results are reported in nanograms per milliliter (ng/mL).
Measured: Baseline and Post-Intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start30 May 2024
- Primary completion1 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, double-blind, placebo-controlled study uses a pre-post design to evaluate the combination of Cordyceps supplementation and Fartlek training in soccer athletes. Sixteen eligible players are randomly allocated via a lottery draw into two parallel groups, with eight participants per group. The Fartlek-Cordyceps (FC) group undergoes structured Fartlek training and receives a daily 500 mg Cordyceps capsule. The Fartlek-Placebo (FP) group follows the identical training program but receives a physically matched placebo capsule. To eliminate bias, an independent researcher prepares and codes the capsules. Both the athletes and the laboratory assessors remain blinded to the allocation until all analyses are complete. The study tracks muscle damage (CK, IL-6, IL-10), oxidative stress (SOD, MDA), bone metabolism (BaLP, OST), and VO2max. Baseline equivalence is rigorously checked, and between-group inferences are determined using change scores.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surabaya State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bayu Agung Pramono, Surabaya State University
- Investigators
- Muhammad Muhammad, Dr., Study chair, Surabaya State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726979
- Sponsor's protocol ID
- B/116160 /UN38.III.1/LK.04.00/
- Other IDs
- 003/KEPK/X/2024
- Acronym
- COR-FAST
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) collected during the trial will be made available to qualified researchers. Specifically, we will share the raw, de-identified datasets containing the baseline and post-intervention measurements of all primary and secondary outcomes, including muscle damage markers (Creatine Kinase), inflammatory markers (Interleukin-6, Interleukin-10), oxidative stress markers (Superoxide Dismutase, Malondialdehyde), cardiorespiratory fitness scores (VO2max), and bone metabolism markers (Bone Alkaline Phosphatase, Osteocalcin). Additionally, basic demographic data such as age, body mass index (BMI), and physiological characteristics will be provided. Personal identifying information of the soccer athletes will be completely removed to ensure strict participant confidentiality. The study protocol and statistical analysis plan will also be shared alongside the dataset to facilitate proper interpretation of the shared data.
Publications
Buonocore D, Negro M, Arcelli E, Marzatico F. Anti-inflammatory Dietary Interventions and Supplements to Improve Performance during Athletic Training. J Am Coll Nutr. 2015;34 Suppl 1:62-7. doi: 10.1080/07315724.2015.1080548.
PubMed 26400438Cerqueira E, Marinho DA, Neiva HP, Lourenco O. Inflammatory Effects of High and Moderate Intensity Exercise-A Systematic Review. Front Physiol. 2020 Jan 9;10:1550. doi: 10.3389/fphys.2019.01550. eCollection 2019.
PubMed 31992987Phull AR, Ahmed M, Park HJ. Cordyceps militaris as a Bio Functional Food Source: Pharmacological Potential, Anti-Inflammatory Actions and Related Molecular Mechanisms. Microorganisms. 2022 Feb 10;10(2):405. doi: 10.3390/microorganisms10020405.
PubMed 35208860Modric, Toni & Versic, Sime & Sekulic, Damir. (2021). Relationship Between Yo-Yo Intermittent Endurance Test-Level 1 and Match Running Performance in Soccer: Still on the Right Path?. Polish Journal of Sport and Tourism. 28. 16-20. 10.2478/pjst-2021-0021.
Helgerud J, Hov H, Mehus H, Balto B, Boye A, Finsas L, Hoff J, Wang E. Aerobic high-intensity intervals improve V̇O2max more than supramaximal sprint intervals in females, similar to males. Scand J Med Sci Sports. 2023 Nov;33(11):2193-2207. doi: 10.1111/sms.14470. Epub 2023 Aug 22.
PubMed 37608507Lee CT, Huang KS, Shaw JF, Chen JR, Kuo WS, Shen G, Grumezescu AM, Holban AM, Wang YT, Wang JS, Hsiang YP, Lin YM, Hsu HH, Yang CH. Trends in the Immunomodulatory Effects of Cordyceps militaris: Total Extracts, Polysaccharides and Cordycepin. Front Pharmacol. 2020 Nov 30;11:575704. doi: 10.3389/fphar.2020.575704. eCollection 2020.
PubMed 33328984Nash D, Hughes MG, Butcher L, Aicheler R, Smith P, Cullen T, Webb R. IL-6 signaling in acute exercise and chronic training: Potential consequences for health and athletic performance. Scand J Med Sci Sports. 2023 Jan;33(1):4-19. doi: 10.1111/sms.14241. Epub 2022 Oct 8.
PubMed 36168944Ashraf SA, Elkhalifa AEO, Siddiqui AJ, Patel M, Awadelkareem AM, Snoussi M, Ashraf MS, Adnan M, Hadi S. Cordycepin for Health and Wellbeing: A Potent Bioactive Metabolite of an Entomopathogenic Cordyceps Medicinal Fungus and Its Nutraceutical and Therapeutic Potential. Molecules. 2020 Jun 12;25(12):2735. doi: 10.3390/molecules25122735.
PubMed 32545666
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Combined Effects of Cordyceps Supplementation and Fartlek Training on Inflammatory, Oxidative Stress, Muscle Damage, and Bone Metabolism Biomarkers (IL-6, IL-10, SOD, MDA, CK, BaLP, OST) in Soccer Players
- ClinicalTrials.gov ID
- NCT07726979
- Acronym / sponsor ID
- COR-FAST / B/116160 /UN38.III.1/LK.04.00/
- Conditions
- Muscle Damage, Athletic Performance, Oxidative Stress, Inflammation, Bone Metabolism, Cardiorespiratory Fitness
- Keywords
- Cordyceps supplementation, Herbal adaptogens in sport, Sports recovery, Athletic performance, Fartlek, Soccer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Surabaya State UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the Study:This study aims to evaluate the effectiveness of combining Cordyceps supplementation and fartlek training as a recovery and performance enhancement strategy for soccer players. Muscle injuries often occur when athletes train intensely without adequate recovery. Cordyceps contains bioactive compounds with anti-inflammatory and antioxidant properties, while Fartlek training is designed to improve cardiovascular endurance. This study analyses how this combination affects both the physiological recovery and physical performance of soccer players. Research Question: Does the combination of Cordyceps supplementation and Fartlek training effectively reduce muscle damage, decrease oxidative stress, promote bone metabolism, and improve cardiorespiratory fitness in soccer players? Methodology and Biomarkers: To answer this question, the study evaluates specific physiological indicators from the participants' blood samples and physical tests. Muscle damage and recovery are assessed through creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10). Oxidative stress levels are monitored using superoxide dismutase (SOD) and malondialdehyde (MDA). Bone metabolism and health are measured via bone alkaline phosphatase (BALP) and osteocalcin (OST). Additionally, improvements in the athletes' aerobic capacity and overall physical performance are determined by measuring their maximal oxygen consumption (VO₂max).
Detailed description
High-intensity athletic training, such as soccer, places rigorous physiological stress on the human body, frequently leading to exercise-induced muscle damage (EIMD), systemic inflammation, and elevated oxidative stress. When recovery periods are insufficient, these factors culminate in persistent fatigue, compromised bone metabolism, and an increased risk of injury. This study investigates a novel, multifaceted recovery and conditioning paradigm by combining the adaptogenic properties of Cordyceps supplementation with the cardiovascular demands of Fartlek training. Mechanistic Framework of Cordyceps and Fartlek TrainingCordyceps contains potent bioactive compounds, including cordycepin, polysaccharides, adenosine, and mannitol. These constituents exhibit strong anti-inflammatory, antioxidant, and anti-apoptotic properties at the cellular level. By counteracting the excessive accumulation of free radicals and downregulating pro-inflammatory pathways (such as NF-$\kappa$B activation), Cordyceps is hypothesised to accelerate structural muscle repair. Concurrently, Fartlek training-a form of continuous training with alternating bursts of high and low intensity-acts as a potent stimulus for cardiovascular and aerobic conditioning, driving adaptations in capillary density and mitochondrial efficiency. Physiological and Biomarker Profiles This trial utilises a comprehensive panel of serum and physical biomarkers to map the synergistic effects of the intervention: Inflammatory Response \& Muscle Damage: The study monitors the kinetics of interleukins to evaluate the shift from a pro-inflammatory state to an anti-inflammatory recovery environment. Interleukin-6 (IL-6) serves as a marker of acute metabolic and inflammatory stress, while interleukin-10 (IL-10) is analysed to track the activation of anti-inflammatory signalling. Additionally, Creatine Kinase (CK) levels are measured as a direct indicator of sarcolemmal disruption and micro-tears in muscle fibres. Oxidative Stress Regulation: To evaluate the antioxidant capacity, the trial quantifies Malondialdehyde (MDA), a primary byproduct of lipid peroxidation, against the activity of Superoxide Dismutase (SOD), an essential endogenous antioxidant enzyme responsible for neutralising superoxide radicals. Bone Metabolism and Turnover: High-impact sports alter bone remodelling. This study assesses the skeletal response to the combined protocol by tracking Bone Alkaline Phosphatase (BALP), a specific marker of osteoblastic bone formation, and Osteocalcin (OST), a non-collagenous protein essential for bone matrix mineralisation and metabolic regulation. Aerobic Power and Adaptation: Beyond biochemical markers, the ultimate physiological translation of enhanced recovery is measured via maximal oxygen consumption (VO₂max). This metric serves to evaluate whether the accelerated recovery mediated by Cordyceps allows athletes to achieve superior cardiorespiratory adaptations during Fartlek conditioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, double-blind, placebo-controlled study uses a pre-post design to evaluate the combination of Cordyceps supplementation and Fartlek training in soccer athletes. Sixteen eligible players are randomly allocated via a lottery draw into two parallel groups, with eight participants per group. The Fartlek-Cordyceps (FC) group undergoes structured Fartlek training and receives a daily 500 mg Cordyceps capsule. The Fartlek-Placebo (FP) group follows the identical training program but receives a physically matched placebo capsule. To eliminate bias, an independent researcher prepares and codes the capsules. Both the athletes and the laboratory assessors remain blinded to the allocation until all analyses are complete. The study tracks muscle damage (CK, IL-6, IL-10), oxidative stress (SOD, MDA), bone metabolism (BaLP, OST), and VO2max. Baseline equivalence is rigorously checked, and between-group inferences are determined using change scores.
| Arm | Type | Receives |
|---|---|---|
| The Fartlek-Cordyceps (FC) group | Experimental | Other: Fartlek Training Program, Dietary Supplement: Cordyceps sinensis SupplementationThe dietary supplement intervention consists of oral administration of Cordyceps sinensis extract. Participants in the experimental group (Fartlek-Cordyceps) are required to ingest a daily dosage of 500 mg Cordyceps sinensis per capsule. The dosing protocol is strictly timed to maximize absorption and recovery: one capsule is taken every night before bed, and on training days, an additional capsule is administered exactly 1 hour prior to the Fartlek session. This supplementation runs concurrently with the physical training period. To maintain the double-blind design, capsules are identical to the placebo in appearance and taste. This targeted timing aims to protect muscle fibers from acute training stress during exercise and accelerate cellular repair overnight, ultimately acting to suppress inflammatory responses, mitigate oxidative damage, and support bone metabolism markers under high physiological loads. |
| The Fartlek-Placebo (FP) group | Placebo comparator | Other: Fartlek Training Program, Dietary Supplement: PlaceboParticipants assigned to this comparator arm undergo a structured Fartlek training program while receiving a placebo intervention to maintain the trial's double-blind design. The physical training protocol consists of continuous running sessions with alternating intensity bursts, identical in frequency, duration, and workload to the experimental group. For the supplementation control, participants are required to orally ingest a daily placebo capsule that is visually identical to the active treatment, matched exactly for size, shape, color, and taste. The dosing schedule mimics the experimental protocol: one capsule is taken every night before bed, and on training days, one capsule is administered 1 hour prior to the Fartlek session. This arm serves to isolate the physiological adaptations of the physical training alone and controls for the placebo effect on muscle damage, inflammation, oxidative stress, bone metabolism, and VO2max. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fartlek Training ProgramThe progressive fartlek programme was performed in the morning, three times weekly for four weeks, with each athlete required to reach 85% of maximal heart rate | Other | The Fartlek-Cordyceps (FC) group, The Fartlek-Placebo (FP) group |
| Cordyceps sinensis SupplementationThe dietary supplement intervention consists of oral administration of Cordyceps sinensis extract. Participants in the experimental group (Fartlek-Cordyceps) are required to ingest a daily dosage of 500 mg Cordyceps sinensis per capsule. The dosing protocol is strictly timed to maximize absorption and recovery: one capsule is taken every night before bed, and on training days, an additional capsule is administered exactly 1 hour prior to the Fartlek session | Dietary supplement | The Fartlek-Cordyceps (FC) group |
| PlaceboThe control intervention consists of oral administration of a placebo capsule. The placebo is completely inert and contains no active ingredients, but it is manufactured to be physically identical to the active Cordyceps sinensis supplement in size, shape, color, and taste to preserve the double-blind trial design. Participants in the Fartlek-Placebo (FP) group follow the exact same dosing schedule as the experimental group: one placebo capsule is taken every night before bed, and on designated training days, an additional capsule is ingested exactly 1 hour prior to commencing the Fartlek running session. This exact timing controls for the psychological and physiological behavioral effects of pill-taking routines. This intervention allows researchers to establish a true baseline to evaluate whether changes in muscle damage, systemic inflammation, oxidative stress, and aerobic capacity are driven by the active Cordyceps compound or by the training protocol alone. | Dietary supplement | The Fartlek-Placebo (FP) group |
Primary outcome
Change from Baseline in Serum Creatine Kinase (CK) Concentration After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Serum Creatine Kinase (CK) is measured to evaluate the extent of exercise-induced muscle damage. Blood samples are analyzed using an automated biochemistry analyzer. An increase in CK levels indicates muscle fiber disruption, while lower post-exercise levels in the intervention group suggest a protective effect of the supplement. Results are reported in Units per Liter (U/L)
Change from Baseline in Serum Interleukin-6 (IL-6) Levels After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Serum Interleukin-6 (IL-6) is measured as a primary biomarker for acute systemic inflammatory responses and muscle-derived cytokine secretion induced by high-intensity training. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Lower change scores indicate suppressed systemic pro-inflammatory pathways. Results are reported in picograms per milliliter (pg/mL)
Change from Baseline in Serum Interleukin-10 (IL-10) Levels After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Serum Interleukin-10 (IL-10) is measured to evaluate the anti-inflammatory response to exercise stress. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Higher change scores or maintained levels of this cytokine indicate a well-regulated anti-inflammatory mechanism that assists in tissue repair and resolution of inflammation. Results are reported in picograms per milliliter (pg/mL).
Change from Baseline in Superoxide Dismutase (SOD) Activity After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Superoxide Dismutase (SOD) activity is measured to assess endogenous antioxidant enzyme defenses against oxidative stress induced by strenuous exercise. Blood samples are analyzed using a spectrophotometric assay kit. Higher change scores indicate enhanced antioxidant capacity to neutralize reactive oxygen species (ROS). Results are reported in Units per milliliter (U/mL).
Change from Baseline in Serum Malondialdehyde (MDA) Levels After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Serum Malondialdehyde (MDA) is measured as a key biomarker of lipid peroxidation to quantify oxidative damage to cell membranes resulting from high-intensity training. Blood samples are analyzed using the Thiobarbituric Acid Reactive Substances (TBARS) spectrophotometric assay. Lower change scores signify mitigated oxidative stress and cellular protection. Results are reported in nanomoles per milliliter (nmol/mL)
Change from Baseline in Maximal Oxygen Uptake (VO2max) After 4 Weeks of Training
Time frame: Baseline and Post-Intervention (Week 4)
Maximal oxygen uptake (VO2max) is measured to evaluate improvements in cardiorespiratory fitness and aerobic capacity. Participants undergo a standardized physical fitness field test (such as the Yo-Yo Intermittent Recovery Test or a progressive shuttle run test) specific to soccer players. Higher change scores indicate superior aerobic adaptation and physiological conditioning. Results are reported in milliliters of oxygen per kilogram of body weight per minute (mL/kg/min).
2 secondary outcomes
Change from Baseline in Bone Alkaline Phosphatase (BALP) Levels After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Change from Baseline in Serum Osteocalcin (OST) Concentration After 4 Weeks
Time frame: Baseline and Post-Intervention (Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Results publication: PubMed 26400438Buonocore D, Negro M, Arcelli E, Marzatico F. Anti-inflammatory Dietary Interventions and Supplements to Improve Performance during Athletic Training. J Am Coll Nutr. 2015;34 Suppl 1:62-7. doi: 10.1080/07315724.2015.1080548.
- Results publication: PubMed 31992987Cerqueira E, Marinho DA, Neiva HP, Lourenco O. Inflammatory Effects of High and Moderate Intensity Exercise-A Systematic Review. Front Physiol. 2020 Jan 9;10:1550. doi: 10.3389/fphys.2019.01550. eCollection 2019.
- Results publication: PubMed 35208860Phull AR, Ahmed M, Park HJ. Cordyceps militaris as a Bio Functional Food Source: Pharmacological Potential, Anti-Inflammatory Actions and Related Molecular Mechanisms. Microorganisms. 2022 Feb 10;10(2):405. doi: 10.3390/microorganisms10020405.
- Results publicationModric, Toni & Versic, Sime & Sekulic, Damir. (2021). Relationship Between Yo-Yo Intermittent Endurance Test-Level 1 and Match Running Performance in Soccer: Still on the Right Path?. Polish Journal of Sport and Tourism. 28. 16-20. 10.2478/pjst-2021-0021.
- Results publication: PubMed 37608507Helgerud J, Hov H, Mehus H, Balto B, Boye A, Finsas L, Hoff J, Wang E. Aerobic high-intensity intervals improve V̇O2max more than supramaximal sprint intervals in females, similar to males. Scand J Med Sci Sports. 2023 Nov;33(11):2193-2207. doi: 10.1111/sms.14470. Epub 2023 Aug 22.
- Results publication: PubMed 33328984Lee CT, Huang KS, Shaw JF, Chen JR, Kuo WS, Shen G, Grumezescu AM, Holban AM, Wang YT, Wang JS, Hsiang YP, Lin YM, Hsu HH, Yang CH. Trends in the Immunomodulatory Effects of Cordyceps militaris: Total Extracts, Polysaccharides and Cordycepin. Front Pharmacol. 2020 Nov 30;11:575704. doi: 10.3389/fphar.2020.575704. eCollection 2020.
- Results publication: PubMed 36168944Nash D, Hughes MG, Butcher L, Aicheler R, Smith P, Cullen T, Webb R. IL-6 signaling in acute exercise and chronic training: Potential consequences for health and athletic performance. Scand J Med Sci Sports. 2023 Jan;33(1):4-19. doi: 10.1111/sms.14241. Epub 2022 Oct 8.
- Results publication: PubMed 32545666Ashraf SA, Elkhalifa AEO, Siddiqui AJ, Patel M, Awadelkareem AM, Snoussi M, Ashraf MS, Adnan M, Hadi S. Cordycepin for Health and Wellbeing: A Potent Bioactive Metabolite of an Entomopathogenic Cordyceps Medicinal Fungus and Its Nutraceutical and Therapeutic Potential. Molecules. 2020 Jun 12;25(12):2735. doi: 10.3390/molecules25122735.
- UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) collected during the trial will be made available to qualified researchers. Specifically, we will share the raw, de-identified datasets containing the baseline and post-intervention measurements of all primary and secondary outcomes, including muscle damage markers (Creatine Kinase), inflammatory markers (Interleukin-6, Interleukin-10), oxidative stress markers (Superoxide Dismutase, Malondialdehyde), cardiorespiratory fitness scores (VO2max), and bone metabolism markers (Bone Alkaline Phosphatase, Osteocalcin). Additionally, basic demographic data such as age, body mass index (BMI), and physiological characteristics will be provided. Personal identifying information of the soccer athletes will be completely removed to ensure strict participant confidentiality. The study protocol and statistical analysis plan will also be shared alongside the dataset to facilitate proper interpretation of the shared data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Muhammad, Dr. study chair
Surabaya State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fartlek Training Program and Cordyceps sinensis Supplementation in people with Muscle Damage and Athletic Performance, run by Surabaya State University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Serum Creatine Kinase (CK) Concentration After 4 Weeks (time frame: Baseline and Post-Intervention (Week 4)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726979, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.