Protocol summary

Study aim
The aim of the present study was to investigate the effect of short-term Royal Energy supplementation on muscle damage, fatigue, and pain response in male athletes to exhaustive aerobic exercise.
Design
This study is a randomized, single-blind, placebo-controlled trial involving 28 male athletes aged 20 to 30 years. Participants will be randomly assigned to one of two groups: the Royal Energy supplement group (n = 14) and the placebo group (n = 14). Both groups will engage in a similar training program prior to the start of supplementation and will provide blood samples for the measurement of lactate, dehydrogenase, and creatine kinase at four-time points (before and after two bouts of activity).
Settings and conduct
Faculty of Physical Education and Sport Sciences, Razi University, Kermanshah
Participants/Inclusion and exclusion criteria
Inclusion Criteria Age and Gender: Participants must be adult males between the ages of 18 and 35. Health Status: Participants must be in good general health and have no chronic illnesses or serious medical problems. Exercise History: Participants must have at least a few months of experience in aerobic exercise. Exclusion Criteria Chronic Diseases: Individuals with chronic diseases such as diabetes, heart disease, or respiratory problems are not eligible to participate in the study. Allergic Sensitivities: Individuals with a history of severe food or supplement allergies, especially to royal jelly, are excluded from the study.
Intervention groups
Royal Energy Supplement Group This group will receive short-term Royal Energy supplements for a specified period before and after exhausting aerobic activities. Control Group (Placebo) This group will receive a placebo, which is an inactive powder designed to resemble the Royal Energy supplement in both appearance and taste.
Main outcome variables
Muscle damage, fatigue, and pain response

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241108063634N1
Registration date: 2024-12-24, 1403/10/04
Registration timing: prospective

Last update: 2024-12-24, 1403/10/04
Update count: 0
Registration date
2024-12-24, 1403/10/04
Registrant information
Name
Sahel Golyarani
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 4478
Email address
sahelgolyarani1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-30, 1403/10/10
Expected recruitment end date
2025-01-09, 1403/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Short-Term Royal Jelly Supplementation on Muscle Damage, Fatigue, and Pain Responses in Male Athletes After Exhaustive Aerobic Exercise
Public title
Investigating the effect of Royal Energy supplements on reducing muscle damage in male athletes during exhausting aerobic activities
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age and Gender: Participants should be adult males (usually between 20 and 30 years of age) to specifically examine the effects of supplementation on this age group. Health Status: Participants should be assessed for general health and must not have any chronic illnesses or serious medical problems that might affect the results of the study. Exercise History: Participants should have at least a few months of experience in aerobic exercise activities to adapt well to the training protocols and supplements. No Use of Similar Supplements: Participants should refrain from taking any similar sports supplements (such as protein, amino acids, etc.) for a specified period before the start of the study to obtain more accurate results. Aerobic Fitness: Participants should be able to perform strenuous aerobic activities, which may include running, cycling, or other sports. Informed Consent: All participants must sign a consent form indicating their awareness of the study’s aims, methods, and potential risks. These corrections enhance clarity and ensure grammatical accuracy.
Exclusion criteria:
History of Chronic Diseases: Individuals with chronic diseases such as diabetes, heart disease, or respiratory problems (e.g., asthma) are not eligible to participate in this study Allergic Sensitivities: Individuals with a history of severe allergies to foods or supplements, especially royal jelly, should refrain from participating in the study Age and Gender: Individuals under 20 years of age or over 30 years of age, as well as pregnant or lactating women, are not eligible to participate in this study. Concurrent Medication: Individuals currently taking medications that may interact with the supplements used in this study, including nonsteroidal anti-inflammatory drugs (NSAIDs) or blood thinners, are not eligible to participate in the study Inability to Perform Exercise: Participants who are unable to perform strenuous aerobic activity or have mobility limitations are not eligible to participate in this study History of Similar Supplement Use: Individuals who have used similar supplements within a specified period prior to the study should refrain from participating to avoid affecting the results
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, a simple randomization method will be employed. Each participant will be assigned a unique identification number and then allocated to one of two groups using a random number table. This revision maintains the original meaning while enhancing readability.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is a crucial aspect of clinical study design that helps minimize bias and enhance the accuracy of results. In the study titled "Investigating the Effect of Short-Term Royal Energy Supplementation on Muscle Damage, Fatigue, and Pain Response in Male Athletes to Exhaustive Aerobic Exercise," a one-sided blinding method will be utilized. Below is a detailed explanation of the blinding procedure: 1. Definition of One-Sided Blinding One-sided blinding refers to a situation where only the participants are unaware of the type of intervention they are receiving (either the Royal Energy Supplement or a placebo), while the researchers and investigators know which intervention is being administered. This approach aims to reduce the psychological effects that participants' expectations may have on the study outcomes. 2. Methods of Blinding - Use of Placebo: For the control group that does not receive the supplement, a placebo (such as an inert powder) will be used that closely resembles the actual supplement in appearance and taste. This similarity ensures that participants cannot distinguish between the real supplement and the placebo. - Training Participants: Prior to the start of the study, participants will be informed that they may receive either a supplement or a placebo but will not be told which one they are assigned to. This helps maintain the integrity of the blinding process. - Data Collection Protocols: Researchers will conduct data collection and assessments in a manner that does not reveal any information about the type of intervention to participants. This includes using independent questionnaires and assessments that are designed without reference to the intervention type. 3. Monitoring Compliance with Blinding - Continuous Monitoring: The research team will continuously monitor adherence to blinding protocols to ensure that no information is inadvertently disclosed to participants regarding their type of intervention. - Periodic Assessments: Throughout the study, assessments will be conducted to evaluate whether participants can correctly identify their intervention type. This helps gauge the effectiveness of the blinding process.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Razi University of Kermanshah
Street address
No. 8, University Blvd, Kermanshah Province, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Approval date
2024-10-02, 1403/07/11
Ethics committee reference number
IR.RAZI.REC.1403.026

Health conditions studied

1

Description of health condition studied
Disorders of Muscles
ICD-10 code
G71.8
ICD-10 code description
Other primary disorders of muscles

Primary outcomes

1

Description
Muscle injuries
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling

2

Description
Fatigue and pain response
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
Using a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Royal Energy Supplement Group will receive short-term Royal Energy supplementation for a specified period before and after exhausting aerobic exercise. The aim of this group is to investigate the positive effects of the supplement on reducing muscle damage, fatigue, and pain response.
Category
Prevention

2

Description
Control group: This group will receive a placebo, which is an inactive powder designed to closely resemble the Royal Energy supplement in both appearance and taste. The purpose of the placebo group is to provide a baseline for comparison with the group receiving the Royal Energy supplement, allowing researchers to determine the true effects of the supplementation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
The Razi University of Kermanshah
Full name of responsible person
Manouchehr Heidari
Street address
No. 9, Razi University Blvd؛ Taq Bostan, Faculty of Physical Education and Sports Sciences.
City
Kermanshah
Province
Kerman
Postal code
6714967346
Phone
+98 83 3428 3270
Email
mhaidary2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Razi University of Kermanshah
Full name of responsible person
Kianoush Chaghamirza
Street address
No. 9, Razi University Blvd؛ Taq Bostan, Razi University.
City
kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
Kianoush.Chaghamirza@Razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Razi University of Kermanshah
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
The Razi University of Kermanshah
Full name of responsible person
Manouchehr Heidari
Position
Assistant Professor of Sports Pathology
Latest degree
Ph.D.
Other areas of specialty/work
Sports Pathology
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
mhaidary2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The Razi University of Kermanshah
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Email
R.hoseini@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The Razi University of Kermanshah
Full name of responsible person
Sahel Goliarani
Position
Master's Degree
Latest degree
Bachelor
Other areas of specialty/work
Sports Pathology
Street address
No. 9, Razi University Blvd؛ Taq Bostan, Faculty of Physical Education and Sports Sciences.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3278
Email
sahelgolyarani1374@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be recorded in the SPSS software and will be available
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as a reference
From where data/document is obtainable
sahelgolyarani1374@gmail.com
What processes are involved for a request to access data/document
If the explanation for the data request would be convincing it will be given in 3 days.
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