NCT07726979

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Cordyceps supplementationHerbal adaptogens in sportSports recoveryAthletic performanceFartlekSoccer

Outcome Measures

Primary Outcomes (6)

  • 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)

    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)

    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).

    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).

    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)

    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).

    Baseline and Post-Intervention (Week 4)

Secondary Outcomes (2)

  • Change from Baseline in Bone Alkaline Phosphatase (BALP) Levels After 4 Weeks

    Baseline and Post-Intervention (Week 4)

  • Change from Baseline in Serum Osteocalcin (OST) Concentration After 4 Weeks

    Baseline and Post-Intervention (Week 4)

Study Arms (2)

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.

Other: Fartlek Training ProgramDietary 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.

Other: Fartlek Training ProgramDietary Supplement: Placebo

Interventions

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

The Fartlek-Cordyceps (FC) groupThe Fartlek-Placebo (FP) group

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

The Fartlek-Cordyceps (FC) group
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.

The Fartlek-Placebo (FP) group

Eligibility Criteria

Age18 Years - 20 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Football Laboratory, Faculty of Sports Science and Health

Surabaya, Jawa Timur - East Java, 60213, Indonesia

Location

Related Publications (8)

  • 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.

  • Cerqueira 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.

  • Phull 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.

  • Modric, 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.

    RESULT
  • 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.

  • Lee 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.

  • Nash 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.

  • Ashraf 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.

Related Links

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Muhammad, Dr.

    Surabaya State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In addition to the participants and outcome assessors, the biostatistician responsible for the final statistical data analysis was also kept completely anonymous in this trial. All datasets were provided to data analysts using pre-coded group labels (Fartlek cordyceps and Fartlek Placebo) instead of the actual intervention names. The independent researcher who generated the randomization allocation securely holds the master code, and it will not be leaked or disclosed to data analysts until all statistical calculations and interpretation of conclusions are formally completed.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student and Principal Investigator

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 27, 2026

Study Start

May 30, 2024

Primary Completion

July 1, 2024

Study Completion

July 2, 2024

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The de-identified individual participant data and requested supporting documents (Study Protocol and Statistical Analysis Plan) will become available to external researchers beginning 3 months after the official publication of the primary research article in a peer-reviewed journal. Access to the shared data will remain open for a duration of 3 years following the initial publication date, after which the availability will be re-evaluated by the principal investigator.
Access Criteria
Access to the IPD will be limited to qualified academic or clinical researchers who provide a methodologically sound research proposal that aims to achieve the objectives approved by the authors. To request access, researchers must submit their protocol and data-use rationale via email directly to the principal investigator. Data will be shared exclusively for non-commercial scientific synthesis or meta-analysis purposes. Upon approval of the proposal, a secure, password-protected data file will be delivered to the applicant. The requesting party must sign a data-use agreement pledging to maintain absolute participant confidentiality and strictly prohibiting any attempts to re-identify the individual soccer athletes.

Locations