Plain English Summary
Background and study aims
Recently, there has been a lot of interest in the effects of essential oils on athletic performance and health. Essential oils are natural oils which are taken from plants and other natural sources. They have been used for many years in alternative medicine, as they are thought to help improve the function of the mind and body. This study will look at oils from the Clinopodium serpyllifolium (white micromeria - a type of evergreen shrub) and Cymbopogon citratus (lemon grass) plants to find out if they are able to improve lung function and athletic performance in healthy male athletes.
Who can participate?
Healthy male university students aged between 18 and 22 from the faculty of physical education at An-Najah National University in Nablus-Palestine.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group inhale Clinopodium serpyllifolium volatile oil mixed with 2ml of normal saline (salt water) which has been turned into a vapor. Those in the second group inhale Cymbopogon citratus volatile oil mixed with 2ml of normal saline (salt water) which has been turned into a vapor. Before and five minutes after inhalation, participants complete a breathing test using a spirometer (device used for measuring the about of air breathed in and out) to test their lung function. In addition, before and after inhalation, participants run 800 metres in a stadium to find out if inhaling the oil will improve their athletic performance.
What are the possible benefits and risks of participating?
Participants may benefit from improved lung function and athletic performance as a result of taking part in the study. There are no notable risks involved with taking part in this study.
Where is the study run from?
An-Najah National University (Palestinian Territory)
When is the study starting and how long is it expected to run for?
May 2016 to November 2016
Who is funding the study?
An-Najah National University (Palestinian Territory)
Who is the main contact?
Dr Hamzeh Al Zabadi
halzabadi@najah.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hamzeh Al Zabadi
ORCID ID
http://orcid.org/0000-0002-0721-9561
Contact details
Faculty of Medicine and Health Sciences
An-Najah National University
Nablus
00970
Palestinian Territory
+970 59 8046276
halzabadi@najah.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of inhalation of Clinopodium serpyllifolium and Cymbopogon citratus volatile oils on lung function and exercise performance: A quasi-experimental uncontrolled before-and-after study
Acronym
Study hypothesis
The aim of this study is to examine the effects of inhalation of Clinopodium serpyllifolium and Cymbopogon citratus volatile oils on a group of athlete male students on their lung functions and exercise performance.
Ethics approval
Institutional Review Board (IRB) at An Najah National University, 30/08/2016, ref: 11/08/2016
Study design
Single-centre non randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung function and exercise performance
Intervention
Twenty male university students from the faculty of physical education at An-Najah National University in Nablus-Palestine will be randomly assigned into two different groups. The study is single blind at participant level.
Group 1: Participants will nebulize with Clinopodium serpyllifolium oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.
Group 2: Participants will nebulize with Cymbopogon citratus oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.
Participants in both groups will complete a 800 m run test in a stadium race before and after inhalation of the oils, they will inhale the oils five minutes before running. Lung function tests will be undertaken using a spirometer before and 5 minutes after inhalation.
Intervention type
Phase
Drug names
Primary outcome measure
Lung function is measured using spirometry before and 5 minutes after inhalation of the volatile oils.
Secondary outcome measures
Athletic performance is measured using a 800 meter run test before and after inhalation of the volatile oils.
Overall trial start date
01/05/2016
Overall trial end date
10/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy
2. Male university students from the faculty of physical education at An-Najah National University in Nablus, Palestine
3. Aged between 18-22 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
20
Participant exclusion criteria
Suffering any disease.
Recruitment start date
15/10/2016
Recruitment end date
25/10/2016
Locations
Countries of recruitment
Palestinian Territory
Trial participating centre
An-Najah National University
West Bank
Nablus
00970
Palestinian Territory
Sponsor information
Organisation
An-Najah National University
Sponsor details
Public Health Division
Nablus
00970
Palestinian Territory
+970 59 8046276
halzabadi@najah.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
An-Najah National University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned for publication of study results in a peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Hamzeh Al Zabadi (halzabadi@gmail.com)
Intention to publish date
01/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list