Research Paper

Research Proposal for Studies Involving Human Participants

PROJECT DETAILS

1. Project Title:
To determine if 2mg/kg, 3mg/kg or 4mg/kg of caffeine is most beneficial for repeated sprint performance in female team sport athletes.

2. Aims and objectives of the study (200 words maximum)
Aims:
The primary aim of this study is to determine if 2, 3 or 4mg/kg of caffeine significantly improves 20-meter repeated sprint performance in female athletes.
Secondary aim of the study is to gain further knowledge on the impact of caffeine in female team sport athletes.

3. Lay summary of the study (500 words maximum)
Note: This should be understandable to a non-expert and should not be a copy of the research proposal. It should include the reasons for the research, the background to it and why the area is important to investigate.

This study aims to find the ideal dose of caffeine for female athletes. Caffeine can play an important role during exercise, as it’s known to increase alertness and physical performance. Caffeine is used by both men and women as an ergogenic aid during exercise. Although caffeine ingestion influences physical performance in both males and females, due to physiological differences and hormonal changes, men and women differ in their response to caffeine. Caffeine is more effective in men in comparison to women because of their ability to regulate temperature, fluids and sugar levels in the body. As a result, this means that when testing the effectiveness of caffeine during exercise, gender matters. Previous studies have only been male dominated or mixed gender, this study will only focus on female performers as there is a lack of research in this area. Thus, the primary intent of conducting this study is to assist female repeated sprint athletes, and staff to gain a better understanding on the appropriate dose of caffeine they can consume. It will be beneficial to identify the impact that the different doses have on the female body and discover if consuming 2mg/kg of caffeine can have the same result on repeated sprint performance as 4mg/kg. It will be useful knowledge as taking the lower dosage will minimise side effects. Moreover, the study will provide the basis for better insights into the optimal amount of caffeine for the best ergogenic results. Therefore, this study will expand on the existing literature and provide new additional information on the most appropriate caffeine dosage for female athletes.

4. Start date of study:
17/02/2020

5. End date of study:
22/04/2020

6. Start date for data-collection:
Note: Data collection should not commence before final ethical approval is confirmed.
24/02/2020

7. Location of the study:
The project will be undertaken at Loughborough College, the testing will be conducted in the 2012 Fitness Centre using the lab facility (FS2) and sports hall (FS3).

Yes No
8. Do any of the researchers stand to gain from a particular conclusion of the research study? ☐
☒

If Yes, how do the researchers stand to gain?

APPLICANT DETAILS

9. Name of Applicant (for group submissions enter all applicants):
Tsz Laam Yau (222331)

Curriculum Area:
Sport

Student Email address: 222331@student.loucoll.ac.uk

Name of Supervisor: Marianna Apicella

PARTICIPANT INFORMATION

10. Number of participants to be recruited:
The number of participants will be between 20-25, because studies conducted previously with multiple sprints with similar testing achieved significant results with this sample size (Glaister et al., 2008; Gwacham and Wagner, 2012). As such, the chosen number of participants is sufficient for the study because it will be straightforward to interpret the data and yield significant results.

11. Details of participants (age, gender, special interests etc):
The participants will be female adults aged between 18 and 25 years old and are team-sport athletes.
12. How will participants be selected?
Note: Include the inclusion/exclusion criteria to be used.

Inclusion criteria. Only female athletes who are between 18 and 25 years old will be eligible to take part in the study. Also, only women who are habitual caffeine users, healthy, not injured, team sport athletes, and those who will exercise three times a week will be selected. The participants will train three times a week because it is within the recommended time to achieve maximum power output in a repeated sprint exercise (Kasai et al., 2018).

Exclusion criteria. The choice of female subjects will have some implications to the study. For example, women on the menstrual cycle, using contraception, and pregnant women have significant implications to the results of the study. Studies have reported 100mg/day of additional caffeine consumption increased the risk of 7% miscarriage in pregnant women (Chen et al., 2016). Thus, female athletes who become pregnant during the course of study will be removed immediately. Also, women taking any contraceptives, males, injured athletes, unhealthy athletes, participants with allergies, women who are not within the age bracket (18-25 years old) and women do not train three times per week will be excluded.

13. How will participants be recruited and approached?
Note: If an advertisement or forum post is to be used, please include this in your application to the Sub-Committee.

Participants will be recruited via email using convenience sampling. A participant invitation letter (see Appendix 1) will be sent through via email to coaches from Loughborough University hockey, netball, rugby and basketball teams.

14. Please state the demand on participants’ time:
Note: Where possible, include a breakdown of how long each part of the study will take, as well as a total time demand.

The total time required per session is 45 minutes, and for the 5 sessions, the total time is approximately 3 hours and 45 minutes.

15. Please provide procedures for the chaperoning and supervision of the participants during the study. (required for vulnerable participants or invasive procedures/physical activity).

The participants will be supervised from the moment the trial starts. Also, the participants will be made to fill in a Physical Activity and Readiness Questionnaire (PAR-Q), supplement disclaimer form and informed consent form before starting any physical activity. There will be a lab technician present throughout all testing who is first aid trained. The researcher will supervise each participant and will ensure that they all complete a 5-minute standardised warm-up. The researcher will also assess any changes in heart rate of the participants to ensure that the heart rate does not exceed 85% of their maximum at any point during the trial, this will be monitored after every completed sprint. Once the sprints have been completed, the participants will be instructed to conduct a standardised cool-down for 5 minutes.

16. Please give details of possible risks, discomforts and/or distress to participants. Please include details of cultural issues for participants.

The participants might experience possible discomfort, as they will be asked a personal question such as “are you currently on your menstrual cycle, pregnant or on any form of contraception? “. Also, the participants could experience side effects of caffeine, such as restlessness, increased respiration and heart rate, nervousness or allergies. There is also possibility of risk of injury during exercise.

17. Please provide details of any incentives, reimbursements or payments being offered to the participants.

There are no incentives, reimbursements or payments being offered to the participants.

RESEARCHER SAFETY

Yes No
18. Are there any potential risks to the researchers in this study? ☐
☒

If No, please go to Question 19.
If Yes, please answer the questions 18a-18b below.

18a. What are the potential risks to the researchers?

18b. What measures have been put in place to address these risks?

STUDY DETAILS

19. Description of study design and methodology:
Note: It should be clear what each participant will have to do, how many times, and in what order. All of this information should also be included on the Participant Information Sheet.

Material and Methods

The research design for this study will be a randomised, cross-over double-blind trial. The trial will take place at the Sport Hall (FS3) facility at Loughborough College.

Before the study, the participants need to keep a food diary to replicate the same food intake 24 hours before and on the day of each trial (Limmer et al., 2018). The participants will consume food until 1 hour before they take the capsule to improve athletic performance and reduce the chances of premature exhaustion (Costill, 2007). The participants will also be informed to provide measurements of their height and weight before the sprints as their weight may influence the rate at which caffeine works in the body. Testing process will occur within the same facility every time with the use of similar equipment. In the research, the participants are required to wear similar sport clothing and trainers each time. Testing is carried out at the same time every day. Furthermore, the participants will be requested not to take any other caffeine substance 24 hours before and after consuming the capsule for ethical concerns and to avoid inaccurate results (Lara et al., 2019).

During the study, the participants will each complete a total of five trials, the first trial will be a familiarisation, and then 4 trials will be randomly conducted, with 3 of the trials entailing different doses of caffeine and one trial for the placebo, which will be an identical caffeine-free sugar pill (Beedie, 2006).

The participants will take a caffeine capsule instead of caffeine powder, as it is the preferred form in both research and sport studies (Ali et al., 2016; Spriet, 2014). Moreover, multiple studies using caffeine capsules showed successful and significant results (Ali et al., 2016; Foskett et al., 2009; Puente et al., 2017). The participants will take the capsule 1 hour before the trials with 250ml of water to allow the caffeine to be fully absorbed to maximize performance outcomes (Glaister et al., 2008).

Exercise Protocol
Prior to the experiment, the participants will complete a Physical Activity and Readiness questionnaire (PAR-Q), supplement disclaimer form, and informed consent form (See Appendix 1). The Heart Rate (HR) for each participant will be recorded prior to the experiment, by a HR monitor (Polar FT1, Polar, Finland, Fitnessdigital). The age, height, and weight of each participant will also be recorded, the height and weight will be recorded with a stadiometer (Seca 213, Birmingham, UK) and scales (Seca 813, Birmingham, UK). The testing process will be conducted based on the information presented in research by Kaynak et al. (2017). Before the testing process, the participants will be informed to take a standardized warmup for approximately 5 minutes. Warmup is essential during the sprints to moderate aerobic effects or activity before the experiment (Iaia et al., 2017). Warmup will entail jogging and dynamic stretching for 5 minutes, the participants will need to jog for 3 minutes with a Rate of Perceived Exertion (RPE) of 12, and complete lunges and leg swing for 2 minutes (Glaister et al., 2008). This will be necessary during sprint exercise as it prepares the athlete’s body for aerobic activity. It assists in regulation of blood flow to the body muscles (Sander et al., 2013). In a study by Taylor et al (2013), the impact of a 5-minute warmup in repeated sprints has shown positive impacts, warmup activities for at least 5 minutes before commencing the exercise is essential for aerobic fitness. The study indicated that a 5-minute warmup in repeated sprint performance provides beneficial ergogenic effects like improved power output.

In trial 1, a familiarisation test will be conducted, to enable the participants to get familiar with the testing protocol and this will be essential to minimise unreliable data for future trials. To ensure consistent data across all the trials, they will be carried out ideally at the same time and day of the week (Iaia et al., 2017). After completing the warmup, the participants will start the test. There will be no verbal encouragement during the sprints, because it is difficult to standardised verbal encouragement and all the sprint times for all participants will be kept from them (McNair et al., 1996). Timing gates (Brower TCi Gate, America) will be used to measure speed because it can provide a more accurate and reliable measurement in comparison to a stopwatch, as it uses infra-red signal detectors to detect when the beam is split to record the results (Waldron et al., 2011).

There will be 5X20-meter(m) sprints with 20 seconds active recovery of jogging in between with a set RPE of 8, then a 2-minute rest, followed by another set of 5X20m sprints, and finally a cooling down exercise. The 5X20m sprints were chosen because in team sports critical movements such as achieving maximum acceleration, deceleration, and the ability to change direction at speed within a short distance, is imperative for the athlete’s performance (Jennings et al., 2010). Therefore, to get relevant data in the context of team sports, the study needs to test the athletes’ repeated-sprint performance in similar conditions; as a variety of female team sports (Australian football, soccer rugby union and hockey) involve bursts of speed over shorter distances that does not exceed 20m, the chosen sprint distance is the ideal test (Andrzejewski et al., 2015; Jennings et al., 2010). Moreover, the 20m of straight–line sprints for a total of 10 times were chosen to achieve running velocity (Reinhardt et al., 2019) and to determine the impact induced by the intervention on match performance and to achieve active recovery (Iaia et al., 2017).

Actual team sport uses active recoveries (e.g. basketball, volleyball etc.), therefore this study will replicate this by using active recovery jogging (Crowther et al., 2017; Spencer et al., 2006). The 20 seconds active recovery has been chosen as that is the ideal duration for team sport players to rest (Kaynak et al., 2017). Spencer et al. (2006) explained that active recovery is necessary in team sports that involve short burst of speeds, as active recovery has shown to promote faster clearance of blood lactate and reported to improve power output recovery when undertaken after intense exercise (Connolly et al., 2003; Sökmen et al., 2017). Additionally, active recovery rest is essential to allow the body stretch, repair and for the athlete to recover psychologically and physically (Iaia et al., 2017).

A research by Fletcher and Jones (2004) stated that 2 minutes recovery period is adequate for an average of 20m sprint distant for rugby union players, as well as being a good replication of half time in team sport situations (Kaynak et al., 2017). Furthermore, it is a satisfactory choice as it has been proven as the best, or most effective duration to achieve anaerobic and aerobic metabolism or capacities (Kaynak et al., 2017). Which concludes why the 2 minutes recovery period has been chosen.

The HR will be recorded after the warmup and during every sprint using the HR monitor, the HR will be measured to determine any changes that may occur after ingesting the caffeine capsule (Hirofumi et al., 2001). Based on ethical concerns, the max heart rate (HRmax) of the participant in this study will not be allowed to exceed a threshold of 85% (Hirofumi et al., 2001). Recording HR after the warmup and in every sprint will assist in identifying any changes that may affect the supply of oxygen to muscles (Frikha et al., 2016). Furthermore, after every sprint, RPE will be recorded; recording RPE is essential in determining the intensity of the athletes’ exercise (Davis et al., 2015).

After completing all the sprints, the participants will be informed to start the cool-down exercise for 5 minutes. During cool-down exercise, the participants will engage in light jogging with an RPE of 10 for 3 minutes and gradually decreasing the speed to a walking pace with an RPE of 6 (Kaynak et al., 2017). For the remaining 2 minutes the participants will finish with static stretches, which includes hamstrings, quads and calves stretches (Van Hooren and Peake, 2018). The cool-down is necessary to promote post-exercise recovery among the participants by minimising Delayed Onset Muscle Soreness (DOMS), reduce heart and breathing rates and gradually cool body temperature (Van Hooren and Peake, 2018).

The test protocol will then be repeated for each of the trials – 2,3,4, and 5, being a mixture of 3 caffeine supplements (2mg/kg, 3mg/kg or 4mg/kg) and 1 with the placebo (caffeine-free sugar pill) randomly conducted in a double-blinded manner. As the study involves the use of caffeine, to protect the participants from side effects due to regular intake. The study will be achieved within 5 consecutive weeks, with each trial having a minimum 7 days in between. (Spencer et al., 2006).

Analysis
Data analysis will be done using Statistical Package for the Social Sciences (SPSS) Version 25.0 (IMB, Armonk, NY: IBM Corp, 2016). A two-way within measures ANOVA will be performed on heart rate, sprint times and RPE.

20. Measurements to be taken:
Note: All measurements and samples to be taken from participants should be included here. Measurements can include questionnaire, observations and photographic data.

 Age
 Height
 Weight
 Heart rate
 RPE
 Repeated sprint time

21. What Identifiable Personal Information or Sensitive Personal Information are you collecting:
Note: See ICO guidance on personal data at: https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/key-definitions/what-is-personal-data/

The identifiable and sensitive personal information that will be collected are name, age, height and weight of participants.

22. Does the proposed study involve any of the following? Select those that apply:

22a. Involves taking bodily samples ☐

22b. Involves procedures which are physically invasive (including the collection of body secretions by physically invasive methods) ☐

22c. Is designed to be challenging:
Physically (includes any study involving physical activity) ☒

Psychologically ☐

22d. Involves procedures that are likely to cause:
Physical distress to participants ☒

Psychological distress to participants ☐

Social distress to participants ☐

Emotional distress to participants ☐

22e. Involves intake of compounds additional to daily diet, or other dietary manipulation/supplementation ☒

22f. Involves pharmaceutical drugs (Please refer to published guidelines) ☐

22g. Involves testing new equipment ☐

22h. Involves procedures which may cause embarrassment to participants ☐

22i. Involves use of hazardous materials (Please refer to published guidelines) ☐

22j. Involves methods of contraception ☐

If you have selected any of the above, please give specific details of each of the procedures to be used and arrangements to deal with adverse effects:

To mitigate the risk of injury occurring, before each sprint there will be safety precautions put in place, such as ensuring there is no tripping or slipping hazards in proximity. It is important for the participants to warmup before conducting the sprints to minimize the chance of injures. Finally, to prevent any misunderstanding of the participants physical health to participate in the sprints, they will be required to fill in a PAR-Q before every single session. Any concerning data (e.g. physical health issues) reported by the participants will be directed to occupational health and GP’s, and they will not be able to participate in the study.

The multiple sprint test may cause Delayed Onset Muscle Soreness (DOMS) which is muscles being in pain after a vigorous exercise, this may last from 24 to 72 hours. DOMS is caused by damaged muscle fibres through the process of eccentric exercise (Law and Herbert, 2007). To lower the risk of DOMS the participants are asked to complete a warmup prior to the sprints and a cool down after completion, as studies have found a warmup and cool down can reduce DOMS (Law and Herbert, 2007).

A study has found Maximum Heart Rate (HRmax) that has continuously been exceeded during vigorous exercise can cause poor recovery rates and can increase the chance of cardiac events such as, arrhythmias and chest pain (Atwal et al., 2002). However, during the study the Heart Rate (HR) will be monitored after each sprint to prevent this from occurring, if the participants has exceeded the safe zone of 85% HRmax the participant will immediately be withdrawn from the study (Hirofumi et al., 2001).

A study has found high-speed and sprint running can increase the chances of injuries (Malone et al., 2018). Therefore, the injury risk will be prevented or reduced by allowing the subjects to perform a warmup before the sprints and cool-down once all the sprints has been completed.

The selected caffeine dosage for this study will be relatively safe because caffeine is known to be less harmful in small doses (Temple et al., 2017). Participants who have a known allergy to caffeine will not be accepted to take part in the study. If a participant does have an allergic reaction during trial, a first aid trained laboratory technician will be available throughout each testing session.

CONSENT
Yes No
23. Will written informed consent be obtained from participants? ☒
☐

If Yes, please attach a copy of the consent form to be used.
If No, please explain why written consent is not being obtained:

Refer to Appendix 1.

24. Will any of the participants be from the following vulnerable groups?

Select those that apply:

Children under 18 years of age ☐

Persons incapable of making an informed decision for themselves ☐

Pregnant Women ☐

Prisoners/other detained persons ☐

Adults who are vulnerable because of their social, psychological or medical circumstances ☐

Other vulnerable groups
Please specify: ☐

If you have selected any of the above, please answer the following questions:

24a. What special arrangements have been made to deal with the issues of consent?

24b. Have the researchers obtained necessary police registration/DBS clearance?
Note: Please provide details, including date clearance obtained, or indicate why this is not applicable to your study.

WITHDRAWAL

25. How will participants be informed of their right to withdraw from the study?

The participants will be informed of their right to withdraw prior to commencement of data collection via the participant information sheet as well as verbal reminders.

26. How will participants be informed of the timeframe for withdrawing their data before this has been aggregated in the study or published?

The participants will be informed of the timeframe of their right to withdraw, both verbally and in writing. Participants need to withdraw before 22nd March 2020, after this date the data will be analysed and ready for publish.

STORAGE AND SECURITY OF DATA

27. Will the study include the use of any of the following? Select those that apply:

Observation of participants ☐

Audio recording ☐

Video recording ☐

Yes No N/A
28. Will the collection and storage of the personal data comply with current Data Protection legislation? See ICO Guidance on personal data: https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/key-definitions/what-is-personal-data/
☒
☐
☐

If Yes, please give details of legal basis for processing personal data:

The data collected will be stored on a drive that is only accessible to the researcher and supervisor. All data in written format will be scanned and finally shredded.

Personal data will be processed on the public task basis. Individuals’ rights to erasure and data portability do not apply if you are processing on the basis of public task. However, individuals do have a right to object. Under the General Data Protection Regulation (GDPR), some of the personal data which will be collected from you is categorised as “sensitive data”. The processing of this data is necessary for scientific research in accordance with safeguards. This means that study has gone through an ethical committee to ensure that the appropriate safeguards are put in place with respect to the use of your personal data.

If No, please give details:

Yes No
29. Will participants personal data be stored securely, in line with participants informed consent, and deleted when no longer required for this study
☒
☐

If No, please give details:

Yes No
30. Will study data/results be anonymised at the earliest opportunity (see guidance at https://www.ukdataservice.ac.uk/manage-data/legal-ethical/anonymisation).
☒
☐

If Yes, please explain how data will be anonymised:
If No, please give details:

To ensure confidentiality participants data will be kept anonymous and stored on a password protected computer and cloud-based storage system. The data collected will only be shared with relevant parties that are part of the project. Participants will be numbered to ensure anonymity within the research project. All data will only be shared with the supervisor and will only be use for the purpose of the study.

Yes No N/A
31. Will original hardcopies of study documents (interview notes/transcripts/questionnaires) be securely destroyed after being scanned, encrypted and securely stored on the College’s IT system
☒
☐
☐

If No, please give details:

Yes No N/A
32. Will original recordings (audio/video) and photographs be securely destroyed/deleted after being anonymised, encrypted and retained securely on the College’s IT system.
☐
☐
☒

If No, please give details:

Yes No
33. Will data/results be encrypted and securely stored on the College’s IT system
☒
☐

If No, please give details:

INSURANCE

Note: It is the responsibility of investigators to ensure that there is appropriate insurance cover for the study.

Yes No
34. Is the study to be covered by the College’s insurance? ☒
☐

If No, please confirm who will be insuring the study:

The College maintains in force a Public Liability Policy, which indemnifies it against its legal liability for accidental injury to persons (other than its employees) and for accidental damage to the property of others. Any unavoidable injury or damage therefore falls outside the scope of the policy.
DECLARATION

I confirm that the information included on this form is a true and accurate reflection of the intended study. I understand that material changes to the information provided above will mean that this information is required to be resubmitted prior to commencing or continuing the research. I confirm that the above named investigation complies with published codes of conduct, ethical principles and guidelines of professional bodies associated with my research discipline.
Signature of applicant: Tsz Laam Yau
Signature of Supervisor:

Signature of Head of Department:
(or their nominee)
Date:

Appendix 1: Application Checklist

Please ensure that you have attached copies of the following documentation to your application:

For all applications:
☒
Participant Information Sheet
☒
Informed Consent Form
☒
Risk Assessment
Where applicable:
☐
Willingness to Participate/Assent forms (for studies involving participants under 18)
☐
Parental/Guardian Information Sheet
☐
Children’s Information Sheet
☐
Letter of Approval(s) from Head Teacher(s)
☐
Opt-Out Letters
☒
Health Screen Questionnaire
☐
Questionnaires
☐
Interview Questions
☒
Advertisement/Recruitment material
☐
Evidence of approval from other Committees (including International organisations)
☐
Additional Insurance Cover

Participant invitation letter

Dear Sir/Madam,

I am conducting an experiment as part of a research study to increase our understanding of the benefits of different caffeine doses on multiple sprint performance in female team sport athletes. I am trying to recruit female team-sport athletes aged between 18-25 years old to participate in my study.

To take part in the study, you will be asked to consume a caffeine capsule of 2, 3 and 4mg/kg, depending on what is provided on the day of the trial. There will be 5 trials in total in which one of the trials will be a placebo caffeine-free sugar pill and three of the trials will involve measuring the intake of caffeine in three different dosages. The remaining 1 trial will be a familiarisation trial and you will not have any caffeine intake. The trials will ideally be completed in a 5-week time frame, and in each week, you will be required to come to a trial for 1 day using approximately 45 minutes of your time. You will have to participate in 10X20-meter sprints with an active recovery every 20 seconds and a 2-minute rest after 5 sprints.

If you are interested to participate in the study, there are certain rules you will need to follow. You need to ensure you do not consume caffeine 24 hours before and after the trial. You are not allowed to exercise 24 hours before your trial. You need to wear a similar kit to each trial, sports clothing and trainers. You will not be allowed to eat at least 1 hour prior to the trial starting. You will be asked to keep track of your food consumption meaning you will need to provide a food diary.

The exclusion criteria are the following: any person who is on their menstrual cycle, pregnant or on any form of contraception will not be allowed to take part in this study. Anyone who gets pregnant during the course of the study will also be removed from the study immediately. The reasons why anyone who is using any form of contraception will not be ideal for the study is because contraception can affect the reaction of caffeine. In cases of menstrual cycle during the day of trial, testing will be postponed to a different day.

If you no longer wish to participate and would like to be withdrawn from the study, you can contact me by using this email: 222331@student.loucoll.ac.uk. However, there is a deadline if you do wish to withdraw from the study, you must do so by 22nd March 2020 because the information will be analysed and ready to be published. When data is being destroyed it means all information including contact details and other personal identifiable information will be removed from our system.

All the data you provide will be given in the strictest confidence and in no way will you be identifiable to anyone throughout the process. There is no compensation for participating within this study, however your participation will add great value to the study’s findings. If you are willing and able to participate please contact me to suggest a suitable time of when you are available. If you have any questions, please do not hesitate to contact me.

Yours Sincerely,
Tsz Laam Yau

To determine if 2mg/kg, 3mg/kg or 4mg/kg of caffeine is most beneficial for repeated sprint performance in female team sport athletes.

Adult Participant Information Sheet

Investigators Details:
Name: Tsz Laam Yau (Kellie)
Email address: 222331@student.loucoll.ac.uk

I would like to invite you to take part in my study. Before you decide I would like you to understand why the research is being done and what it would involve for you. I will go through the information sheet with you and answer any questions you have. Talk to others about the study before making a decision if you wish.

What is the purpose of the study?

Previous studies have only been male dominated or mixed gender, this study will only focus on female performers as there is a lack of research in this area. Thus, the primary intent of conducting this study is to assist female repeated sprint athletes and staff to gain a better understanding on the appropriate dose of caffeine they can consume. It will be beneficial to identify the impact that the different doses have on the female body and discover if consuming 2mg/kg of caffeine can have the same result on repeated sprint performance as 4mg/kg. It will be useful knowledge as taking the lower dosage will minimise side effects. Moreover, the study will provide the basis for better insights into the optimal amount of caffeine for the best ergogenic results. Therefore, this study will expand on the existing literature and provide new additional information on the most appropriate caffeine dosage for female athletes.

Who is doing this research and why?

This study is part of a student research project associated with an Undergraduate programme at Loughborough College. The main researcher is Tsz Laam Yau, who studies sports coaching at Loughborough College. The lab technician at the College will be assisting with the research, with Marianna Apicella supervising the overall study.

Are there any exclusion criteria?

The choice of female subjects will have some implications to the study such as women on the menstrual cycle, using contraception, and pregnant women. Women taking any contraceptives, males, injured athletes, unhealthy athletes, participants with allergies, women who are not within the age bracket (18-25 years old), and women do not train three times per week will be excluded. Furthermore, athletes who become pregnant during the course of study will be removed immediately.

What will I be asked to do?

 To take part of the study you will be asked to consume a sugar pill and caffeine capsules of 2, 3, and 4mg/kg with 250ml of water depending on what is provided on the day of the trial.
 There will be a total of five trials, the first trial will be a familiarisation, then the following 4 trails will be randomly conducted, with 3 of the trials entailing different doses of caffeine and one trial for the placebo.
 You will have to conduct multiple sprints of 10 sprints with a 2-minute rest after 5 sprints. But between each sprint there is a 20 seconds active recovery.

Once I take part, can I change my mind?

After you have read this information and asked any questions you may have if you are happy to participate, I will ask you to complete an Informed Consent Form. However, if at any time, before, during or after the sessions you wish to withdraw from the study please just contact me, by using this email: 222331@student.loucoll.ac.uk. You can withdraw at any time, for any reason and you will not be asked to explain your reasons for withdrawing.

However, there is a deadline if you do wish to be removed from the study, which is the 22nd March 2020, because the information will be ready to be published. When data is being destroyed it means all information including contact details and other personal information will be removed from my system.

Will I be asked to attend any sessions and where will these be?

You will be asked to attend a total of 5 sessions over a period of 5weeks, these sessions will be undertaken at Loughborough College (Radmoor Rd, Loughborough LE11 3BT), the testing will be conducted in the sports hall (FS3).

How long will it take?

The total time required per session is 45 minutes, and for the 5 sessions, the total time is approximately 3 hours and 45 minutes. Please do allow yourself some time to get changed.

Are there any disadvantages or risks in participating?

There are possible side effects of caffeine such as, anxiety, insomnia, digestive issues, changes to respiration and heart rate, or frequent urination. Although there are possible side effects of consuming caffeine the amount given within the study reduces the likelihood of experiencing these side effects to low chance, the severity of the side effects is relatively minor, and the expected time of the effects lasting is short. Furthermore, within the study you will be periodically monitored, specifically your heart rate to ensure you never hit a point considered unsafe. Moreover, research has shown low to moderate amount of caffeine intake is safe for most people.

Is there anything I need to do before the sessions?

The study will require you to keep track of your diet 24 hours before and on the day of the trial and you will have to replicate that diet in every trial. You will be asked to not consume any caffeine within 24hours before and after the trails. You will have to also discuss the requirements with your GP to ensure that you are fit and healthy for the study, the GP will also need to assure you do not have caffeine allergy.

What type of clothing should I wear?

Any active wear that is suitable for sprinting, and you must wear suitable running shoes i.e. trainers. You will have to wear similar sport clothing and trainers for each trial.

Data Protection Privacy Notice

Loughborough College will be using information/data from you in order to undertake this study and will act as the data controller for this study. This means that the college is responsible for looking after your information and using it properly.

What personal information will be collected from me and how will it be used?

The personal information will be collected from you will include the following:
 Name
 Contact details
 Age
 Height
 Weight
 Heart rate
 Whether you are pregnant
 Medical conditions (diabetes)
 Allergies
 Whether you take medicine (i.e. blood pressure tablets)

The data collected for the study will only be used in a dissertation and a poster presentation. All the information will be destroyed if you decide to withdraw before the completion date and after 25 weeks when I complete my course (December 2020).

What is the legal basis for processing my personal information?

How long will my personal information be retained?

We will keep identifiable personal information about you for 6 months after the study has finished. All the study data is automatically erased from my college account 25 weeks after I complete my course (December 2020).

Will my personal information be shared with others?

All data will only be shared with the supervisor and investigators. It will only be used for the purpose of the study.

Will my taking part in this study be kept confidential?

To ensure confidentiality participants data will be kept anonymous and stored on a password protected computer and cloud-based storage system. Participants will be numbered to ensure anonymity within the research project. The data collected will only be shared with relevant parties that are part of the project.

How will the anonymised data/results collected from me be used?

The results of the study will be used in a dissertation and a poster presentation.
How long will the anonymised data/results be retained?

All the study data is automatically erased from my college account 25 weeks after I complete my course (December 2020).

I have some more questions; who should I contact?

If you are willing and able to participate please contact me to suggest a suitable time of when you are available. If you have any questions, please do not hesitate to contact me, by using this email: 222331@student.loucoll.ac.uk.

What if I am not happy with how the research was conducted?

If you are not happy with how the research was conducted, please contact the Undergraduate Student Registry, Loughborough College, Radmoor Road, Loughborough, LE11 3BT Tel: 01509 618110. Email: student.registry@loucoll.ac.uk

To make a request relating to your personal information, contact the College’s Data Protection Officer at DPO@loucoll.ac.uk . If you have a concern about the way we are collecting or using your personal data, we request that you contact us in the first instance. Alternatively, you can contact the Information Commissioner’s Office at www.ico.org.uk/concerns .

To determine if 2mg/kg, 3mg/kg or 4mg/kg of caffeine is most beneficial for repeated sprint performance in female team sport athletes.

INFORMED CONSENT FORM
(to be completed after Participant Information Sheet has been read)

Taking Part Please initial to confirm agreement

The purpose and details of this study have been explained to me. I understand that this study is designed to further scientific knowledge and that all procedures have been approved by the Loughborough College Ethics Committee. ———————-

I have read and understood the information sheet and this consent form. ———————-

I have had an opportunity to ask questions about my participation. ———————-

I understand that taking part in the project will involve vigorous exercise and ingestion of supplements. ———————-

I understand that taking part in the study will be physically exhausting. ———————-

I understand that the personal information collected will be name, age, height, weight, food diary, date of birth and contact information. ———————-

I understand that sensitive personal information, such as body mass, height, weight, age, stage of the menstrual cycle, pregnancy or whether I am taking any form of contraception will be collected during this study. ———————-

I understand that I am under no obligation to take part in the study, have the right to withdraw from this study at any stage for any reason, and will not be required to explain my reasons for withdrawing. ———————-

Use of Information

I understand that all the personal information I provide will be processed in accordance with data protection legislation on the public task basis and will be treated in strict confidence unless (under the statutory obligations of the agencies which the researchers are working with), it is judged that confidentiality will have to be breached for the safety of the participant or others or for audit by regulatory authorities. ———————-

I understand that information I provide will be used for publications and research outputs. ———————-

I understand that personal information collected about me that can identify me, such as my name or where I live, will not be shared beyond the study team.

———————-

I agree that information I provide can be quoted anonymously in research outputs. ———————-

If written information is provided by the participant, I agree to joint copyright of the food diary to Kellie Yau. ———————-
———————-

Consent to Participate

I voluntarily agree to take part in this study.

________________________ _____________________ ________
Name of participant [printed] Signature Date

__________________________ _______________________ _________
Researcher [printed] Signature Date

Physical Activity Readiness Questionnaire

Name Date
DOB Age Home Phone Work Phone
Regular exercise associated with many health benefits, yet any change of activity may increase the risk of injury. Completion of this questionnaire is a first step when planning to increase the amount of physical activity in your life. Please read each question carefully and answer every question honestly:
Yes No 1) Has a physician ever said you have a heart condition and you should only do physical activity recommended by a physician?
Yes No 2) When you do physical activity, do you feel pain in your chest?
Yes No 3) When you were not doing physical activity, have you had chest pain in the past month?
Yes No 4) Do you ever lose consciousness, or do you lose your balance because of dizziness?
Yes No 5) Do you have a joint or bone problem that may be made worse by a change in your physical activity?
Yes No 6) Is a physician currently prescribing medications for your blood pressure or heart condition?
Yes No 7) Are you pregnant?
Yes No 8) Do you have insulin dependent diabetes?
Yes No 9) Are you 69 years of age or older?
Yes No 10) Are you allergic to any substances? e.g. Latex
Yes No 11) Do you know of any reason why you should not have your blood taken today?
Yes No 12) Do you know of any other reason you should not exercise or increase your physical activity?

If you answered yes to any of the above questions, talk with your doctor by BEFORE you become more physically active. Tell your doctor your intent to exercise and to which questions you answer yes.
If you honestly answered no to all questions you can be reasonably positive that you can safely increase your level of physical activity gradually.
If your health changes so you then answer yes to any of the above questions, seek guidance from a physician.

Participant signature Date
Supplement Disclaimer Form

Supplementation compiled:

Supplements are for

Supplements weight was supervised and double checked by prior to storage and/or application.

The supplements will only be used by for

I declare that I have compiled the supplements above and I only plan to use them for the intended purpose of which I have already declared. I will also only distribute these to the intended people after they have consented to consuming the supplements and are fully aware of the potential implications.

I personally understand the legal implications of using these supplements for research purposes.

Student signature:

Date:

Staff signature:

Date:

Appendix 2: Insurance – Normal Activities

Cover is automatic if the research is within the UK and limited to the following activities (e.g. normal activities):

i. Questionnaires, interviews, focus groups, physical activity/exercise, psychological activity including Cognitive behavioural therapy;
ii. Venepuncture (withdrawal of blood);
iii. Measurements or monitoring of physiological processes including scanning;
iv. Collections of body secretions by non invasive methods;
v. Intake of foods or nutrients or variation of diet (other than administration of drugs).

All other Research involving human participants, including studies outside of the UK, will not be supported.

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