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Information Sheet

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 and you can withdraw from this study at any time without providing any reasons. 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.

What is this study about?

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.

What information will be collected?

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 de-identified, 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 (information in the attached fitness tests document). Sliema Fight Club Ltd collects and processes personal data in accordance to the General Data Protection Regulation (EU) 2016/679), Data Protection Act 2001 and other subsidiary legislation. 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. All identifiable data collected throughout the duration of this study are crucial to the project and will be destroyed after the completion of the study (31st December 2025).

What are my data protection and privacy rights?

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. In accordance with Article 6(1)(a) of Regulation (EU) 2016/679, the processing of your data will have your signed express permission as the legal foundation.

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, in a password-protected encrypted format by the BioArte Ltd. Data protection officer (DPO) Maria D’Aguanno, can the samples be preserved and referred to in this manner and 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, having a duration of 2 years starting from 31st December 2023, where the data will be stored until 31st December 2025. Following the end of the project (31st December 2025), following a review of the necessity of stored samples, should you agree these samples will be stored in a de-identified manner and all personal data, including the consent form will be destroyed.

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).

Inclusion criteria

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.

Inclusion criteria: 

  • 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.

Exclusion criteria

  • 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.

What will my participation entail?

As part of any subgroup, at the start of the 3-month period (chosen by you as any consecutive 3 months throughout the entire duration of the project (2 years)) 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 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.

What are the benefits of this research?

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 BioArte will guide you in seeking the appropriate medical professional.

What are the potential risks?

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.

Should you encounter any of the above-mentioned risks, kindly contact the DPO (details found on page 5), who will guide you to the appropriate health professional to assist you with medical assistance.

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. Should you require medical professional, the DPO will guide you to directions to the appropriate health professional.

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.

Should you encounter any of the above-mentioned risks, kindly contact the DPO (details found on page 5), who will guide you to the appropriate professional psychologist.

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.

Concluding remarks

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].

    CONSENT FORM

    Gut Microbiome Based Sports Nutrition

    An original signed copy is to be kept by the BioArte Ltd.
    An original signed copy is to be kept by the research partner.

    Principal Investigator: [email protected] | +356 21383758

    Data Protection Officer: [email protected] | +356 21383758

    By agreeing to take part in the study: Gut Microbiome Based Sport Nutrition, you are giving your consent to the points listed in the information sheet and for the appropriate observations to be made by our principal investigator, as well as the collection of the self-collected biological samples.

    The purpose of this study is aimed at determining the influence of diet and exercise on the gut microbiota, and hence how these factors can influence each other and be controlled to improve one another.

    The purpose and details of the study have been explained thoroughly to me by Dr. Maria D’Aguanno, and any difficulties which I have raised have been clarified.

    I declare that:

    • I consent voluntarily to participate as a participant in the study titled Gut Microbiome Based Sport Nutrition.

    • I am a Maltese resident, and I am over eighteen (18) years of age.

    • I have read and understood what the project titled Gut Microbiome Based Sport Nutrition is about and have had the opportunity to ask any questions which were thus answered fully and to my satisfaction.

    • I give my consent to the Principal Investigator and her delegate either to make the appropriate observations/tests or both or take the necessary samples and use to isolate DNA. I am aware of the inconveniences which this might cause.

    • I understand that DNA samples stored in a pseudonymised form will be banked at the BioArte for 5 years beyond the duration of the study (up to 31st December 2030).

    • I understand that no personal or identifiable data will be revealed in any publications, reports or presentations arising from this research.

    • I consent voluntarily to the provision of stool and salivary samples for a duration of three (3) months prior and after the monitoring period.

    • Should any further sampling/analyses of body fluids be required, I request to be informed and I reserve the right to refuse to continue to participate or to withdraw from the study. Should any further analyses unrelated to the purpose indicated above be considered, I wish to be contacted and informed of the purpose of those studies.

    • I understand that the results of this study may be used for medical or scientific purposes and that the results achieved from this study in which I am participating may be reported or published: however, I shall not be personally identified in any way, either individually or collectively, without my express written permission.

    • I am under no obligation to participate in this study and am doing so voluntarily. I understand that I can change my mind about participation, at any time, by notifying the data protection officer of my decision to end participation in this project. Should I decide to do so, that decision will in no way affect my care or treatment.

    • I am not receiving any remuneration for participating in this study nor any compensation will be given to me as the participant nor will I be owed any funds, at this moment or in the future, due to any invention(s) resulting from research and development using my specimen(s).

    • I understand that information collected as part of this research may include personal data such as age, gender, health status diet, and/or genetic data related to polymorphisms on metabolic genes. This data will be stored securely in accordance with GDPR regulations and will not be shared outside of the BioArte without my permission.

    • I understand that, under the General Data Protection Regulation (GDPR) and national legislation, I have the right to access, rectify, and where applicable, ask for the data concerning me to be erased. I understand that all identifiable personal data, shall be destroyed at the end of the project.

    • I also acknowledge that I have rights over the use of my own information and can request for it to be deleted at any time if desired without the need for a reason to be provided.

    • I understand that Data which can lead to your identity (consent form) will only be held by the Data protection officer Maria D’Aguanno who is duly bound not to release any traceability data to other research investigators or to any third parties. I understand that 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.

    • I understand all potential risks involved in taking part in this research project including possible negative side effects (including but not limited to a change in appetite and bowel movements) which may occur due to changes made during dietary plans based on results from microbiome analysis; the possibility of a breach or misuse of data leading to identity theft or other forms damages; implications regarding confidentiality issues.

    • I have been provided with a copy of the information letter and understand that I will also be given a copy of this consent form

    In case of queries during the study, I may contact

    Data Protection Officer: Dr. Maria D’Aguanno [email protected] | +356 21383758

    Kindly tick the applicable option:

    Kindly tick the applicable option:


    Principal Investigator: Dr. Christine Podirini

    TITLE: LIFESTYLE & HEALTH QUESTIONNAIRE

    Client Personal Information

    Once you have given consent above, kindly proceed in filling out the questions below:

    EXERCISE

    On a scale of 0 to 10, (0 being the least and 10 being the most) how important are the following fitness goals to you?

    Weight loss:
    Muscle gain:
    Sports performance:
    Health improvement:

    DIET

    On a scale of 0 to 10, (0 being not at all and 10 being very much) do you consider your overall diet to be healthy?

    What is your daily salt intake: low, medium, or high?
    (For reference, the standard by WHO for a healthy diet is ≤5g/day).

    What is your daily sugar intake: low, medium, or high?
    (For reference, the standard by NHS for a healthy diet is ≤30g/day)

    What is your daily fat intake: low, medium, or high?
    (For reference, the standard by NHS for a healthy diet is ≤30g/day)

    On a scale of 0 to 10, (0 being ineffective and 10 being highly effective) how effectively are you able to control your temptations for junk food?

    LIFESTYLE

    On a scale of 0 to 10, (0 being the least and 10 being the most) how would you rate your average level of stress?

    OCCUPATION

    Does your occupation require you to wear shoes with a heel (e.g., dress shoes, work boots)?

    RECREATION

    MEDICAL

    Additional Notes