Title of the study: Gut Microbiome based Sports Nutrition
Principal Investigator – Dr. Christine Podrini
Data protection officer (DPO) – Dr. Maria D’Aguanno
Dear Potential Participant,
You are kindly being asked to participate in a research study aimed at investigating if sport performance and recovery are associated with a particular microbiome profile. You have been contacted as we think you are a suitable candidate for this study. Being a suitable candidate requires you to tick one of three categories, along with the generic inclusion criteria. More information regarding the project and participant categorisation can be found below.
Taking part in this study is voluntary. This information letter explains what the study is about, the possible risks and benefits, and your rights as a research participant. Should you be willing to participate you will be requested to fill in a consent form provided. You will be provided with a copy of the information and consent form if you choose to participate in the study. Refusing to participate will not impact the training and care that will be given to you.
Please read this letter carefully to understand what is involved. After you have read the letter, feel free to ask any questions you may have to DPO Dr. Maria D’Aguanno on +356 21383758.
This study aims to investigate if sport performance and recovery are associated with a particular gut microbiome (the type and quantity of bacteria in the gut) profile.
Personal information such as name and contact number will be collected through the consent form as well as the attached questionnaire. The principle of data minimisation has been kept – the only personal information on the consent form is the name, surname, age and contact number. The samples and associated data will be stored and saved in the laboratory, following BioArte’s sample retention policy with data saved in a password protected encrypted format that meets legal requirements and the consent form stored under lock and key. Paper based consent forms shall be kept for 3 years, then converted into an electronic format (scanned) and the electronic format will then be saved in a password protected encrypted format that meets legal requirements as per BioArte’s sample retention policy. The paper-based consent form will then be destroyed (shredded). You understand that if data in the BioArte databases are anonymized, it cannot be destroyed upon request as it is unidentifiable and untraceable.
Other data being collected shall include type and intensity of the physical activity and diet description. As a participant, your participation will be required for a 3-month period. At the beginning of which you will need to provide a stool sample for microbiota analysis. The resulting analysis of this sample will allow us to provide you with a personalised diet and exercise program, according to the category you will form part of. Should you be given a diet and exercise program, you will need to follow these programs for 3 months as the monitoring period, whilst also performing certain fitness tests. To enable the performance of the given exercise program, a 3-month membership at the Sliema Fight Club Ltd will be sustained. During these 3 months, you will need to provide regular updates on your dietary intake and exercise routines through an online pseudonymised portal. This online portal will act as a logbook and a link between you and the researcher without any identifiable data. You will be assigned a randomised number to log into this online portal and upload your diet and exercise updates weekly. After the 3-month monitoring period, you will need to provide an additional stool sample and one saliva sample for the assessment of the genotype with relation to the microbiota, as well as the re-evaluation of the microbiota and one self-finger-prick lactate measurement as for routine training.
This study has been approved by the Research Ethics Committee of the Faculty of Health Sciences of the University of Malta. All data will be processed strictly in accordance with the provisions of the General Data Protection Regulation (EU) 2016/679 for the sole purpose of this study.
The biological samples will only be partially anonymised (pseudonymised) by coding, that is, they will be given a random number as a label, hence the sample collection will be an “Identifiable Collection.” Only through this code, which is safely stored by the BioArte Ltd. Data protection officer (DPO) Maria D’Aguanno, can the samples preserved and referred to in this manner be connected to the personal and medical data.
Data which can lead to your identity (consent form) will only be held by the Data protection officer, (DPO) Maria D’Aguanno who is duly bound not to release any traceability data to other research investigators or to any third parties. All samples taken for this study will be allocated a random, non-sequential code by the data protection officer and sent to the principal investigator. Apart from the data protection officer, all the other research investigators will not have access to the consent forms or personal data but will only have access to the samples and the pseudonymised accompanying sample forms.
Your samples along with the pseudonymised information will only be stored for the duration of the project. Following the end of the project, should you agree, these samples will be stored in a fully anonymised manner, allowing them to be utilised for research at a further stage, without any identification of the sample doner or their related medical data.
As a participant, you have the right, under the General Data Protection Regulation (GDPR) and national legislation that implements and further specifies the relevant provisions of said regulation, to access, rectify and where applicable ask for the data concerning you to be erased. If you decide to withdraw from the study, your identifiable data (the consent form) shall be destroyed (shredded). Any identifiable sample of human origin will also be destroyed (incinerated).
Your contact information, along with the sample personal and medical information, will only be accessible through the DPO and will not be disclosed to third parties, including employers, governmental agencies, insurance providers, or educational institutions, unless required to do so by Maltese law or the Maltese courts, unless you give us specific permission to do so. In addition, the BioArte Ltd. will not divulge any information without your explicit consent to spouses, partners, family members, or your family doctor.
If you feel that you would not like to proceed with the study, you shall be free to withdraw your participation at any time, without any consequences whatsoever.
Full confidentiality is guaranteed with respect to all information obtained verbally, in writing, or as a result of any of the tests that we carry out. Nothing will be published which in any way can disclose your identity.
No compensation will be given to you as a participant nor will you be owed any funds, at this moment or in the future, due to any invention(s) resulting from research and development using your specimen(s).
As previously mentioned, the inclusion criteria will allow the first step towards categorisation of participants into three (3) groups. The details for these categories can be found within the questionnaire attached with this letter. The questionnaire will allow you to be categorised into one of three subcategories: non-sports trainee control group, low-performance fit sports trainee, and high-performance fit sports trainee. The type of dietary and fitness program, as well as whether or not you will be allocated one will depend on the subgroup you are categorised into, in accordance with the inclusion and exclusion criteria, the questionnaire, as well as on-site fitness tests.
- Being between 19-50 years of age.
- Do not follow a specific diet e.g., Ketogenic.
- Subcategories: Low and high-fitness subgroups are to provide a medical certificate for fitness.
- Pre-existing health conditions: Participants with any pre-existing health conditions which may influence physical performance, including but not limited to cardiovascular disease, chronic obstructive pulmonary disease, diabetes, amongst others.
- Allergies: food intolerances and allergies to certain foods.
- Injuries: Participants with any injuries which may influence physical performance, including but not limited to; fractures, sprains, strains, amongst others.
As part of any subgroup, at the start of the 3-month period you will be required to provide a stool sample, along with an additional stool and saliva sample at the end of the 3-month period. You shall be provided with a self-sampling kit for faecal that will be used to obtain microbiome data.
According to the subgroup you are categorised into following sampling, you will be given a dietary plan (the plans are listed as an addendum to this letter) following gut microbiota results and required to undergo a 3-month monitoring period. This dietary plan will be specific to you, according to your microbiota results and exercise program.
During the monitoring period, you will need to keep a daily/weekly diary of your dietary intake and exercise routines, as done via the online platform previously described. This information shall be sent to the principal investigator to identify scientific trends and follow-up anything necessary.
The monitoring period will involve regular communication with the research team to ensure that you are following the prescribed dietary and exercise regimen. This communication shall be done through the dedicated portal that only you can access and will not contain any personal information but will only be identifiable through the random number previously generated. The length of this monitoring period is essential to enable the researchers to collect enough data on the impact of the dietary plan on your microbiota and overall health.
After this period, at the end of the 3 months, an additional stool and saliva sample will be asked of you for re-evaluation of microbiota data. The saliva sample acquired will provide data related to single nucleotide variations (single nucleotide polymorphisms also known as SNP’s) within injury and recover related genes (CRP, IL-6, TNF, SOD2, GSTL1 and GSTT1), respectively. All analysis will be carried out at The BioArte Laboratories, which is fully licensed as Diagnostic labs by the Maltese Health Authority. The collected data may be used by the principal investigator to provide dietary recommendations to you as a participant in this study.
By participating in this project, in addition to improving your overall health and fitness performance, you will also contribute to the advancement of scientific knowledge and understanding of the relationship between microbiota, genetics, and exercise performance. The data collected and analysed in this study may also have broader social benefits, including informing the development of personalised nutritional and exercise plans for athletes and non-athletes alike, and potentially leading to the development of new pharmaceutical products and treatments. By participating in this project, you may also gain a greater understanding of the importance of maintaining a healthy gut microbiome and how this can impact your overall health and well-being. Due to the performance of exercises which may induce strenuosity, the research will provide you with a sport cardiologist if needed for any tests involved in cardiac heart rate, a physiotherapist for any injuries which may arise throughout the 3-month process, as well as a psychologist for any psychological assistance.
There is no significant physical risk should you wish to participate.
Participants in this study may experience possible consequences from changes in their diet and exercise routine. Some possible adverse consequences that may result from dietary changes include:
- Changes in appetite: due to changes in their diet or exercise routine. This may result in increased or decreased hunger, or changes in food preferences. Participants should be advised to monitor their hunger levels and to report any significant changes.
- Changes in bowel movements: Changes in diet or exercise may also result in changes in bowel movements, such as increased or decreased frequency, changes in consistency, or discomfort. Participants should be advised to monitor any changes in their bowel movements and to report any significant changes or discomfort.
- Certain dietary changes may not be suitable for everyone, and could have adverse effects on health, particularly if not monitored properly.
- Possibility of nutritional imbalances, allergic reactions, amongst any unforeseen health consequences.
The routine lactate measurement via the finger-prick test may bring about some discomfort.
Remote risk of participants experiencing any type of panic/seizure attack during the gym. The Sliema Fight Club will not be held responsible for any such experiences, and these will be tackled by trained provided personnel including the sports cardiologist and psychologist provided by the BioArte.
The logging and tracking of dietary and exercise programs may result in adverse effects:
- Invasion of privacy: Participants may feel uncomfortable or violated through their detailed daily monitoring of food intake and exercise habits.
- Psychological impact: Constant tracking and monitoring of food intake and exercise may lead to increased stress, anxiety, or feelings of guilt in participants. This may also exacerbate any existing issues related to body image or eating disorders.
The study’s findings may have limited generalisability towards the broader population due to the self-selection bias of the participants. Individuals who are already interested in their diet and exercise habits may be more likely to enrol, potentially skewing the results and limiting the applicability to the general population.
The BioArte Ltd. has implemented the necessary and appropriate security measures, including but not limited to secure sample storage facilities, the implementation of a strict coding technique for pseudonymisation, and the use of a robust IT environment for the purpose of ensuring the security of data processing, reducing the risk associated with the storage of samples and data.
In the extremely unlikely event that you will suffer any consequences directly related to the project diet and exercise routine during the 3-month period of the project that should result in any medical care, treatment will be provided to you free of charge.
Kindly review this information sheet carefully. It is entirely up to you whether you participate or not.
You will be required to sign the Consent Form if you choose to participate and join the study team. The contribution of both the biological sample and the medical information needs your permission. Along with this information sheet, you will receive a copy of the consent form that has been signed for your records.
Should you require additional information, or which to communicate any changes to addresses, you may contact the BioArte Data protection officer (DPO) Dr. Maria D’Aguanno at the BioArte Ltd. offices during office hours on +356 2138 3758, or by email on [email protected].