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Acute effects of Ashwagandha consumption on aerobic and anaerobic power and fatigue in soccer players

Protocol summary

Study aim
survey of the acute effects of Ashwagandha supplement on soccer players after 14 days of consuming this supplement to aerobic and anaerobic capacity and fatigue.
Design
A clinical trial with a control group, supplement consumption, triple blind, randomized, on 30 subjects. The rand function of Excel software is used for randomization.
Settings and conduct
Subjects are selected from soccer players in Neiriz city and randomly placed in two groups of supplement and placebo. A session before the introduction, measurements related to anthropometric characteristics and some physical fitness factors are performed. after 14 days of supplementation, post-test will be conducted like the pre-test.Triple blinding is done and the researcher, team coach and players are unaware of the contents of the capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Soccer players, 18-30 years, not suffering from physical and mental diseases, not undergoing any type of treatment during the research period, not using tobacco, alcohol, sports supplements and not following Special diet. Exclusion criteria: injury and Digestive disorders, Unwillingness to continue participating in research
Intervention groups
Intervention group: 15 people consume two 300 mg capsules of Ashwagandha (Olimp Ashwagandha 600 Sport) every day, (in the morning and evening) for14 days. Control group: 15 people consume two 300 mg capsules of placebo (Corn starch) every day, in the morning and evening for14 days.
Main outcome variables
The main variables include aerobic and anaerobic capacity and fatigue.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230910059392N3
Registration date: 2023-11-09, 1402/08/18
Registration timing: retrospective

Last update: 2023-11-09, 1402/08/18
Update count: 0
Registration date
2023-11-09, 1402/08/18
Registrant information
Name
Hakimeh Akbari
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 23 3153 2165
Email address
h.akbari@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-17, 1402/06/26
Expected recruitment end date
2023-10-03, 1402/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acute effects of Ashwagandha consumption on aerobic and anaerobic power and fatigue in soccer players
Public title
The Effect of Ashwagandha Supplements on Football Players
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
General health and no physical and motor complications such as back pain and knee pain Regular physical activity (bodybuilding exercises, soccer training at least three months prior to screening for this study) will be considered eligible
Exclusion criteria:
If taking dietary supplements, medications or steroids used to increase physical performance A history of heart disease, diabetes, Digestive diseases, depression, stroke or neurological disorder Participants if taking sedatives .misuse of drugs, orthopedic or surgical injury in the last 6 months
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization, blocks of 4, 6 and 8, block sequence randomly and the unit of randomization is the individual, which is done using the RAND function of Excel statistical software. The epidemiologist consultant will prepare a list of subjects based on random numbers created through Excel software (between 0 and 1) before starting the work. Subjects are entered into the random chain in order from number 1 to 30.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the packaging of the placebo similar to the original drug is done by someone other than the researcher (as an informed person) and the drugs are assigned a code. The packages are delivered to the team coach along with a form where the names of the players are noted in the relevant codes. The coach is not aware of the contents of the packages. Medicines are distributed among the players randomly and the players (participants) are also unaware of the contents of the packages. At the end, the examiner performs the tests without knowing about the groupings and writes down the names in a form. The data collected from the pre-test and post-test forms are provided to the statistical analyst to analyze the data based on codes and names. Finally, after analyzing the data, decoding is done.
Placebo
Used
Assignment
Other
Other design features
The functional tests of this study are specific to soccer.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in Semnan medical science research
Street address
Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education
City
Semnan
Province
Semnan
Postal code
35131- 19111
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
IR.SEMUMS.REC.1402.122

Health conditions studied

1

Description of health condition studied
Ashuganda and football
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Aerobic power
Timepoint
Aerobic capacity will be measured before and 48 hours after Ashwagandha consumption
Method of measurement
Aerobic power is measured with a stopwatch to determine the desired record and distance, and the YOYO IRL1 test is used to evaluate aerobic power.

2

Description
Anaerobic power
Timepoint
Anaerobic capacity will be measured before and 48 hours after Ashwagandha consumption
Method of measurement
Anaerobic power is measured with a stopwatch to determine the desired record and distance. RAST test is used to measure anaerobic power.

3

Description
Fatigue
Timepoint
Fatigue will be measured before and 48 hours after Ashwagandha consumption
Method of measurement
Fatigue is measured with a stopwatch to determine the desired record and distance, which the RAST test is used to evaluate fatigue.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 15 people consume two 300 mg capsules of placebo (Corn starch) every day, in the morning and evening for14 days.
Category
Other

2

Description
Intervention group: 15 people consume two 300 mg capsules of Ashwagandha (Olimp Ashwagandha 600 Sport) every day, (in the morning and evening) for14 days.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Ni Raz sports stadium, Chaman field
Full name of responsible person
Beigi Mohammad Reza
Street address
Neiriz Shohada Stadium, takhti street, neiriz, fars, IR Iran
City
Neiriz city
Province
Semnan
Postal code
7491865517
Phone
+98 71 5384 1012
Email
mohammadrezabeygi1997@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Akbari Hakimeh
Street address
Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education
City
Semnan
Province
Semnan
Postal code
1911135131
Phone
+98 23 3153 2165
Email
h.akbari@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University
Full name of responsible person
Akbari Hakimeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education
City
Semnan
Province
Semnan
Postal code
1911135131
Phone
+98 21 3153 2165
Email
h.akbari@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Akbari Hakimeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education
City
Semnan
Province
Semnan
Postal code
1911135131
Phone
+98 23 3153 2165
Email
h.akbari@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Akbari Hakimeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Iran, Semnan, Semnan University, Faculty of Humanities, Department of Physical Education
City
Semnan
Province
Semnan
Postal code
1911135131
Phone
+98 23 3153 2165
Email
h.akbari@semnan.ac.ir

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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Provide information on the main outcome
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Only researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data in review studies and meta-analysis is allowed
From where data/document is obtainable
It is possible to receive the data via e-mail: h.akbari@semnan.ac.ir
What processes are involved for a request to access data/document
Submission of documents is one month after the request.
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