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 Citrus sinensis (sweet orange) flower and Mentha spicata (spearmint) leaves 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 20 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 M. spicata oil mixed with 2ml of normal saline (salt water) which has been turned into a vapor. Those in the second group inhale C. sinensis flower 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 (devise used for measuring the about of air breathed in and out) to test their lung function. In addition, before and after inhalation, participants run 1500 metres in a stadium to find out if inhaling the oil has improved 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?
April 2016 to October 2016
Who is funding the study?
Investigator initiated and funded (Palestinian Territory)
Who is the main contact?
Dr Nidal Jaradat
nidaljaradat@najah.edu
Study website
Contact information
Type
Scientific
Contact name
Dr Nidal Jaradat
ORCID ID
http://orcid.org/0000-0003-2291-6821
Contact details
Faculty of Medicine and Health Sciences
An-Najah National University
Nablus
00970
Palestinian Territory
+97 (0)599739476
nidaljaradat@najah.edu
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1/May/ 2016
Study information
Scientific title
The effect of Inhalation of Citrus sinensis flowers and Mentha spicata leave essential 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 compare the effects between the Citrus sinensis flower and Mentha spicata leaves essential oils inhalation among a group of athlete male students on their lung functions
Ethics approval(s)
Institutional Review Board (IRB) at An Najah National University, 03/05/2016, ref: 1/May/2016
Study design
Single-centre randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Other
Study type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Exercise performance and lung function
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 participant level.
Group 1: Participants will nebulize with M. spicata oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.
Group 2: Participants will nebulize with C. sinensis flower oil (0.02ml/kg of body mass of oil) mixed with 2ml of normal saline.
Participants in both groups completed a 1500m run test in a stadium race before and after inhalation of the oils, they inhaled the oils 5 minutes before running. Lung function tests are undertaken using a spirometer before and after inhalation.
Intervention type
Other
Primary outcome measure
Lung function is measured using spirometry before and 5 minutes after inhalation of volatile oil.
Secondary outcome measures
Athletic performance is measured using a 1500 meter run test before and after inhalation of volatile oil.
Overall study start date
01/04/2016
Overall study end date
01/10/2016
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 18-20 years
Participant type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Upper age limit
20 Years
Sex
Male
Target number of participants
20
Participant exclusion criteria
Suffering from any disease
Recruitment start date
22/06/2016
Recruitment end date
22/07/2016
Locations
Countries of recruitment
Palestinian Territory
Study participating centre
An-Najah National University
West Bank
Nablus
00970
Palestinian Territory
Sponsor information
Organisation
An-Najah National University
Sponsor details
Department of Pharmacy
Palestine-West Bank
An-Najah National University
Nablus
00970
Palestinian Territory
+970 (0)9 2345113
info@najah.edu
Sponsor type
University/education
Website
ROR
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of study results in a peer reviewed journal.
Intention to publish date
01/10/2017
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/09/2016 | Yes | No |