Protocol summary

Study aim
This study aimed to investigate the effects of short-term Shilajit supplementation on: Aerobic and anaerobic capacity, Fatigue index, and Serum biomarkers of muscle damage following exhaustive exercise in competitive young taekwondo athletes
Design
A randomized, double-blind, placebo-controlled, parallel-group clinical trial design was employed
Settings and conduct
Study conducted at Ilam University's Sports Science Center under research committee supervision. Randomized allocation of eligible participants into two groups Double-blind design: Participants and researchers unaware of treatment (Shilajit/placebo) Identical capsules used to maintain blinding Continuous monitoring by research team Immediate adverse effect reporting required
Participants/Inclusion and exclusion criteria
Inclusion Criteria Competitive taekwondo athletes aged 18-29 years Minimum rank of blue belt certification No current use of nutritional supplements or performance-enhancing substances Absence of diagnosed chronic diseases or musculoskeletal disorders. Provision of written informed consent Demonstrated compliance with all study protocols Exclusion Criteria Failure to meet any of the aforementioned inclusion criteria
Intervention groups
Shilajit Group: Received 500 mg/day of Shilajit extract Placebo Group: Received an identical-matched placebo
Main outcome variables
Improvement in maximal oxygen uptake (VO₂max) Enhancement of anaerobic power output Reduction in physiological fatigue index Decreased serum concentrations of muscle damage biomarkers (CK, LDH) Accelerated recovery following exhaustive exercise Comparative efficacy evaluation of Shilajit versus placebo on athletic performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241029063535N1
Registration date: 2025-04-10, 1404/01/21
Registration timing: registered_while_recruiting

Last update: 2025-04-10, 1404/01/21
Update count: 0
Registration date
2025-04-10, 1404/01/21
Registrant information
Name
Hadi Abdi
Name of organization / entity
Payam Noor University
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 1052
Email address
abdi.h@pnu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-05-10, 1404/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Short-Term Shilajit Supplementation on Aerobic Power, Anaerobic Power, Fatigue Index, and Muscle Damage Markers Following Exhaustive Running in Young Taekwondo Athletes
Public title
The Effects of Short-Term Shilajit Supplementation in Young Taekwondo Athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
between the ages of 18 and 29 years Absence of chronic diseases or musculoskeletal injuries. No consumption of additional sports supplements or performance-enhancing drugs during the study period. Provision of written informed consent following detailed explanation of the study protocol. Minimum of 3 years of regular competitive Taekwondo training, with a rank of at least blue belt proficiency.
Exclusion criteria:
Current or recent (past month) use of: Sports supplements, Performance-enhancing drugs or Corticosteroids. Prior shilajit supplementation within the preceding 3 months. Diagnosed chronic medical conditions including, Diabetes mellitus, Hypertension, Thyroid dysfunction, Cardiovascular disorders Recent (within the past 6 months) musculoskeletal injuries affecting athletic performance. Recent (past 7 days) consumption of anti-inflammatory or analgesic medications. Taekwondo rank below blue belt (e.g., white, yellow, or green belts). Fewer than 3 years of regular competitive taekwondo training. Declined participation in the exhaustive running protocol. Did not provide written informed consent. Documented hypersensitivity to shilajit or its constituent compounds. Current tobacco use or alcohol consumption.
Age
From 18 years old to 29 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants were randomly allocated to intervention or control groups using a double-blind procedure performed by an independent investigator.
Placebo
Used
Assignment
Parallel
Other design features
No specific design

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ilam University
Street address
Ilam University, Pajoohesh Blvd, Banganj area, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177111
Approval date
2025-03-02, 1403/12/12
Ethics committee reference number
IR.ILAM.REC.1403.054

Health conditions studied

1

Description of health condition studied
This study does not focus on a specific disease. Instead, it examines the efficacy of Shilajit supplementation in enhancing functional performance metrics and mitigating exercise-induced muscle damage.
ICD-10 code
ICD-10 code description

2

Description of health condition studied
No specific disease is being investigated
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Aerobic capacity
Timepoint
Before supplementation (baseline), 24 hours after supplementation.
Method of measurement
The Bruce protocol was employed for assessment of maximal aerobic capacity.

2

Description
Anaerobic power
Timepoint
Before supplementation (baseline), 24 hours after the supplementation.
Method of measurement
The Running-Based Anaerobic Sprint Test (RAST) was utilized to assess anaerobic power.

3

Description
Lactate Dehydrogenase (LDH)
Timepoint
Before supplementation, after supplementation, immediately and 24 hours after an exhaustive running session.
Method of measurement
Using specific kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving 500 mg/day of Shilajit
Category
Other

2

Description
Control group: Receiving placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ilam University
Full name of responsible person
Nabi Shamshaei
Street address
Ilam University, Pajoohesh Blvd, Banganj area, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177111
Phone
+98 84 1222 1052
Email
n.shamsaei@ilam.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University
Full name of responsible person
Abdulhamid Azizi
Street address
Ilam University, Pajoohesh Blvd, Banganj area, Ilam, Iran
City
Ilam
Province
Ilam
Postal code
6939177111
Phone
+98 84 5924 1203
Email
m.bazgir@ilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Payame noor university
Full name of responsible person
Hadi abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Physical Education Payame Noor University of Ilam Daneshjoo Blvd Ilam, Iran
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۹۳۶۱۷۳
Phone
+98 84 3222 1052
Email
abdi.h@pnu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame noor university
Full name of responsible person
Hadi abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Physical Education Payame Noor University of Ilam Daneshjoo Blvd Ilam, Iran
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۹۳۶۱۷۳
Phone
+98 84 3222 1052
Email
abdi.h@pnu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Payame noor
Full name of responsible person
Hadi abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Department of Physical Education Payame Noor University of Ilam Daneshjoo Blvd Ilam, Iran
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۹۳۶۱۷۳
Phone
+98 84 3222 1052
Email
abdi.h@pnu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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