Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older
Phase: NA
Conditions: Atrial Fibrillation (AF), Heart Failure
Sponsor: Azienda Ospedaliero-Universitaria Careggi

 
April 19, 2021 
Microbiota-Inflammation-Brain Axis in Heart 
Failure: New Food, biomarkerS and Artificial 
Intelligence Approach for the Prevention of 
undeRnutrition in Older (AMBROSIA) 
 
Dear Sir/Madam, 
The information contained in this information sheet is detailed and may appear​
 VERY COMPLEX.​
 We kindly ask you to agree to participate in the study ONLY after having carefully read 
this information sheet and having had a THOROUGH DISCUSSION with the study 
physician, who will dedicate the​
 NECESSARY TIME​
 to help you fully understand what is being proposed. 
 
 

 
 
 
WRITTEN INFORMATION FOR THE PATIENT​
 Version 1 – April 19, 2021 
Study Title:​
 “Ambrosia” food strategy for preventing undernutrition and assessment of new biomarkers in older heart failure 
and atrial fibrillation patients.​
 AMBROSIA: “Microbiota-Inflammation-Brain axis in heart failure: new food, BiomarkerS and AI Approach for the 
prevention of undeRnutrition in Older Heart Failure and Atrial Fibrillation Patients” 
Protocol code, version and date:​
 Version 1 – April 19, 2021​
 EudraCT number: Not applicable 
Study Sponsor:​
 Prof. Amedeo Amedei​
 Department of Experimental and Clinical Medicine​
 Laboratory of Immunology and Microbiome​
 University of Florence​
 amedeo.amedei@unifi.it​
 +39 055 2758330 
Principal Investigator:​
 Prof. Stefano Fumagalli​
 Geriatrics Unit – UTIG, Careggi University Hospital​
 Department of Experimental and Clinical Medicine, University of Florence​
 +39 055 7949429​
 stefano.fumagalli@unifi.it 
Dear Madam / Sir, 
You have been invited to take part in a clinical study, and this document is intended to inform you about the 
nature of the study, its objectives, what your participation will involve, as well as your rights and responsibilities. 
Please read this written information carefully before deciding whether to participate in the study. You will have 
all the time you need to consider your decision. 
You are also free to ask any questions you may have and to raise any concerns that have not been clearly and 
fully addressed. 
If, after reading and understanding all the information provided, you decide to participate in the clinical study, 
you will be asked to sign and personally date the attached Informed Consent form. 
Your personal data will be processed as described in the specific privacy notice regarding the processing of 
 

 
personal data, in compliance with Regulation (EU) 2016/679 – the General Data Protection Regulation (GDPR) – 
and Italian Legislative Decree of 30 June 2003, the Personal Data Protection Code, which implements the GDPR 
into national law. This privacy notice and the related request for consent to data processing will be provided to 
you separately. 
1. Purpose of the Study​
 The aim of the study is to assess the effects of a chocolate bar enriched with probiotics and proteins on the 
nutritional status of older patients with atrial fibrillation and/or heart failure. 
2. Study Characteristics​
 This is a parallel-group study conducted at this facility, which will enroll 120 patients with atrial fibrillation, heart 
failure, or both conditions.​
 "Parallel-group" means that one group of patients will receive the chocolate bar, while another group will 
receive standard care without the bar and will serve as the control group. 
This is an open-label study, meaning that both you and the study physician will know in advance which group 
you are assigned to (intervention or control). 
The total duration of the study is 36 months, but your individual participation will last only 6 months. 
As specified in the attached privacy notice, the study also involves other institutions, brought together in a 
consortium: 
 
 
No. 
Paese 
Nome 
Affiliazione 
1 
Palma de 
Mallorca, 
Spain 
Gwendolyn 
Barceló-Cobli 
jn 
IdISBa, 
Foundation 
Health 
Research Institute of the Balearic 
Islands, Lipids in Human Pathology 
group 
 
 

 
 
 
Edificio​ S, Hospital Universitario 
Son Espases, 
2 
Camerino, 
Italy 
Maria 
Cristina 
Verdenelli 
Synbiotec Srl, 
3 
Dublin 
Ireland 
Marco 
Garcia-Vaque 
ro 
Section of Food adn Nutrition, 
School of Agriculture and Food 
Science, University College Dublin 
4 
Newcastle 
upon Tyne 
United 
Kingdom 
Iain Brownlee 
Northumbria 
University, 
NB144, 
Northumberland​
Building, 
Northumbria University 
5 
Göttingen, 
Germany 
Thomas 
Lingner 
Genevention GmbH, R&D 
 
 
3. What Your Participation in the Study Involves 
If you decide to take part in the study, please note that, after evaluating your eligibility and completing all 
standard medical and instrumental assessments (regardless of your participation in this research), the study will 
include: 
●​ The completion of questionnaires to assess your physical and psychological condition​
 
●​ A blood sample​
 
●​ The collection of stool, urine, and saliva samples for gut microbiome analysis​
 
If you are selected for the experimental group, you will be provided with a chocolate bar enriched with 
probiotics and proteins, to be consumed once daily, 15 minutes before breakfast, for a period of 6 months. 
At the 6-month follow-up visit, the same assessments (questionnaires, blood test, biological sample collection) 
will be repeated. 
Samples will initially be processed at the Laboratory of Immunology and Microbiome, Prof. Amedeo Amedei, 
Department of Experimental and Clinical Medicine, University of Florence. Specifically: 
●​ Bacterial DNA will be extracted from stool and saliva​
 
●​ Serum will be separated from blood​
 
●​ Fecal water will be extracted from stool samples for metabolomic analysis, i.e., the analysis of human 
 

 
and microbial components eliminated from the body​
 
Some serum samples will be sent to Dr. Gwendolyn Barceló-Coblijn, IdISBa – Foundation Health Research 
Institute of the Balearic Islands, Lipids in Human Pathology Group, Son Espases University Hospital, Palma de 
Mallorca, Spain.​
 Fecal water will be sent to Prof. Iain Brownlee, Northumbria University, Newcastle upon Tyne, UK, for further 
analysis. 
All residual biological samples will be stored for 10 years at Prof. Amedei’s lab and may be used for studies 
directly related to the present research. 
4. Assessments You Will Undergo During the Study 
You will be required to visit our center at baseline and again 6 months later. Baseline clinical procedures will be 
the same as standard care: 
●​ Clinical visit for heart failure monitoring​
 
●​ Clinical visit and electrical cardioversion for atrial fibrillation, if needed​
 
●​ Comprehensive geriatric assessment in all cases​
 
The chocolate bar, to be taken once daily, contains probiotics (lactobacilli similar to those found in yogurt), 
proteins, fiber, and coenzyme Q10. These substances are widely used in daily practice. The novelty lies in their 
combination in a single, convenient bar. 
Blood tests will include standard clinical markers plus specific markers of low-grade chronic inflammation, 
related to aging and chronic disease development. Stool samples will be used to analyze gut microbiota. All tests 
and clinical assessments will be repeated at the follow-up visit to evaluate the effects of the intervention 
compared to the control group 
5. Potential Benefits of Participating 
Although not guaranteed, the intake of the bar is expected to help restore gut microbiota balance, improve 
nutrient absorption, and reduce the risk of undernutrition. This is due to the action of proteins and coenzyme 
Q10.​
 In elderly cardiac patients, metabolic disturbances are common and may contribute to muscle loss and the 
development of frailty. This study may help us better understand the relationship between cardiovascular 
disease, physical function decline, and frailty. 
6. Potential Risks of Participation 
Participating in a study always involves potential risks or inconveniences. However, since the nutritional 
components used are common and well-known, no serious or foreseeable adverse events are expected.​
 

 
 In rare cases, temporary intestinal bloating may occur.​
 The only significant risk is potential allergic reactions to specific components. 
For any concerns about risks, you should consult with the study physicians.​
 It is important that you inform the study physician immediately of any changes in your health, regardless of 
whether you believe they are related to the supplement. 
If any medical issue arises as a result of the study, you will receive appropriate medical care. 
6.1 Prohibited Medications 
There are no medications strictly prohibited during the study. However, due to the nature of the assessments, it 
is recommended to avoid regular use of: 
●​ Non-steroidal anti-inflammatory drugs (NSAIDs)​
 
●​ Corticosteroids or other immunosuppressants​
 
●​ Antibiotics​
 
6.2 Risks Related to Unexpected Findings 
The procedures in this study are not expected to reveal findings unrelated to the study purpose (i.e., incidental 
findings). 
7. What Happens in Case of Study-Related Injury? 
The sponsor has taken out insurance coverage with HDI Global SE, in accordance with the Ministerial Decree of 
July 14, 2009. This policy covers damages caused to participants during the study, including those resulting from 
negligence, error, or accident. 
Coverage includes: 
●​ Maximum of €7,500,000 per patient​
 
●​ Maximum of €1,000,000 per protocol​
 
Coverage is valid for injuries occurring during the trial period, provided the damage appears within 24 months of 
the study end and the claim is submitted within 36 months. 
You retain the right to seek compensation directly from those responsible for any harm.​
 Signing this consent form does not waive any of your legal rights. 
If you have a personal insurance policy, you are advised to consult your provider to ensure that participation will 
 

 
not affect your coverage. 
Exclusions from insurance coverage include: 
●​ Unauthorized studies or deviations from approved protocols​
 
●​ Damages unrelated to the trial​
 
●​ Damages to pregnant women or fetuses if no prevention measures are described in the protocol​
 
●​ Claims based on the product’s lack of effectiveness​
 
●​ Claims related to non-compliant equipment or chemicals​
 
●​ Claims involving HIV-related immunodeficiency or diagnostic errors​
 
●​ Damages from invasive or surgical procedures (excluding standard injections or blood draws)​
 
Coronavirus and Pandemic Exclusion:​
 The policy excludes all damages, injuries, losses, or disruptions directly or indirectly caused by: 
●​ Any Coronavirus (e.g., COVID-19, SARS, MERS-CoV)​
 
●​ Any Filovirus (e.g., Ebola, Marburg)​
 
●​ Any epidemic or pandemic declared or not​
 
●​ Any mutation, variation, or threat thereof​
 
8. Possible Alternatives 
This study is designed to enhance standard clinical care by testing a new combination of nutritional 
supplements and evaluating their effects.​
 If you choose not to participate, you will continue to receive optimal care, based on current clinical guidelines. 
9. What Happens If You Decide Not to Participate 
Your participation is entirely voluntary. You are free to decline or withdraw at any time without giving a reason, 
simply by notifying the study physician, Prof. Stefano Fumagalli (055 7949429, stefano.fumagalli@unifi.it).​
 In such cases, no further data will be collected, and you may request the deletion of any previously collected 
data. 
Your current and future medical care will not be affected by your decision. Your doctors will continue to treat 
you with the same level of care and attention. 
 

 
Your participation may also be discontinued if: 
●​ The physician deems the treatment ineffective​
 
●​ You experience adverse effects​
 
In such cases, you will be informed immediately and alternative treatments will be discussed. 
10. End-of-Study Procedures 
At the end of the study, no special patient procedures are planned beyond standard clinical practice. 
11. Consent to Inform Your General Practitioner 
To best protect your health, you will be asked to inform your general practitioner about your participation in this 
study.​
 Their involvement is important to prevent potential interactions between study supplements and medications 
they may prescribe. 
12. Information About Study Results 
If you wish, you may receive a summary of the general study results, as well as results specific to your 
participation.​
 Study-related websites will not include any personal identifiers, only general summaries of procedures and 
outcomes. These will be publicly accessible. 
If any results are available only in English, you may ask the study physician for assistance in reviewing them. 
13. Additional Information 
There are no costs to you for participating in the study. You will not receive any financial compensation for your 
participation.​
 The study site will receive funding from the Joint Programming Initiative “A Healthy Diet for a Healthy Life” (JPI 
HDHL) 2020: “PREVNUT” for data collection and study management. 
The study protocol has been approved by the Ethics Committee on [insert date].​
 The Committee has confirmed compliance with EU Good Clinical Practice (GCP) and the ethical principles 
outlined in the Declaration of Helsinki. 
If you wish to report any concern about the study, you may contact the Ethics Committee or the Hospital 
Medical Directorate. 
For any questions about the study, your participation, potential harm, or your rights as a participant, please 
contact:​
 Prof. Stefano Fumagalli – 055 7949429 – stefano.fumagalli@unifi.it 
 

 
 
 
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Full name of the physician who                                        Date                     Time  Signature of the physician  
provided the information 
 
 
 
INFORMED CONSENT FORM 
FOR PARTICIPATION IN THE STUDY 
Version 1 – April 19, 2021 
 
Study Title:​
 “Ambrosia” food strategy for preventing undernutrition and assessment of new biomarkers in older heart failure 
and atrial fibrillation patients.​
 AMBROSIA: Microbiota-Inflammation-Brain axis in heart failure: new food, BiomarkerS and AI Approach for the 
prevention of undeRnutrition in Older Heart Failure and Atrial Fibrillation Patients 
Protocol Code, Version and Date:​
 Version 1 – April 19, 2021 
Study Sponsor:​
 Prof. Amedeo Amedei​
 Department of Experimental and Clinical Medicine​
 Laboratory of Immunology and Microbiome​
 University of Florence​
 amedeo.amedei@unifi.it – +39 055 2758330 
Principal Investigator:​
 Prof. Stefano Fumagalli​
 Geriatrics Unit – UTIG, Careggi University Hospital and University of Florence​
 stefano.fumagalli@unifi.it – +39 055 7949429 
 
 
 
 
 
 
 

 
INFORMED CONSENT FORM 
I, the undersigned​
Name: ___________________________  Date of Birth: ___ / ___ / ______​
Place of residence: ___________________________ Street: ___________________________​
Phone: 
___________________________  Address 
(if 
different 
from 
residence): 
___________________________ 
DECLARE THAT 
●​ I have received from Dr./Prof. ___________________________ full and clear explanations regarding the 
request to participate in the above-mentioned research, as outlined in the information sheet, which 
forms part of this consent document. I received a copy of the information sheet on (date): ___ / ___ / 
______ at (time): ______;​
 
●​ I have read the patient information sheet related to this study, understand that participation is entirely 
voluntary, and agree to follow the instructions provided by the study physician;​
 
●​ The nature, purpose, procedures, expected benefits, possible risks and discomforts, and alternatives to 
participating in this clinical study have been clearly explained to me and I have understood them;​
 
●​ I have had the opportunity to ask questions and have received satisfactory answers;​
 
●​ I have had sufficient time to consider whether or not to participate;​
 
●​ I have not been subject to any undue pressure in being asked to give consent;​
 
●​ I have been clearly informed that I am free to choose not to participate or to withdraw from the study at 
any time, without having to provide a reason and without incurring any penalty. Such a decision will not 
affect my relationship with my healthcare providers or the facility where I receive care;​
 
●​ I understand the importance of (and my responsibility for) informing my general practitioner about this 
study. If I choose not to do so, I release both my general practitioner and the study investigators from 
any liability for harm that may result from potential incompatibility between the study product(s) and 
other medical treatments;​
 
●​ I understand that I have the right to request a dated and signed copy of this informed consent form.​
 
 
 
 
 

 
 
THEREFORE, I DECLARE THAT I: 
☐ wish    ☐ DO NOT wish​
 to participate in the study 
☐ wish    ☐ DO NOT wish​
 to be informed of the results of this research by the study physician 
☐ wish    ☐ DO NOT wish​
 to be informed of the study results by the study physician, including any unexpected findings that may arise 
from the procedures performed 
☐ wish    ☐ DO NOT wish​
 to inform my general practitioner of my participation in the study 
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 Full name of legal representative (if applicable)                               Date                     Time  Signature  
If the patient or legal representative is unable to read: 
I have participated in the entire informed consent discussion. I certify that the contents of the consent form and 
all other written materials have been clearly explained and apparently understood by the patient or their legally 
authorized representative. Informed consent was freely given by the patient or their legal representative. 
 
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INFORMATION ON THE PROCESSING OF PERSONAL DATA 
Pursuant to EU General Data Protection Regulation (GDPR) 2016/679 
Study Title:​
 “Ambrosia” food strategy for preventing undernutrition and assessment of new biomarkers in older heart failure 
and atrial fibrillation patients.​
 AMBROSIA: Microbiota-Inflammation-Brain axis in heart failure: new food, BiomarkerS and AI Approach for the 
prevention of undeRnutrition in Older Heart Failure and Atrial Fibrillation Patients 
Protocol Code, Version and Date:​
 Version 1 – April 19, 2021 
Study Sponsor:​
 Prof. Amedeo Amedei​
 Department of Experimental and Clinical Medicine​
 Laboratory of Immunology and Microbiome​
 University of Florence 
Principal Investigator:​
 Prof. Stefano Fumagalli​
 Geriatrics Unit – UTIG, Careggi University Hospital and University of Florence​
 stefano.fumagalli@unifi.it 
1.​ Premise 
It is important to recall the following: 
●​ Personal data means any information capable of identifying – directly or indirectly (i.e., also through 
additional information) – a natural person, the so-called data subject (hereinafter, any reference to the 
data subject refers to the participant in the study; the terms “data subject” and “participant” are used 
interchangeably for the purposes of this document);​
 
●​ Personal data processing refers to any operation carried out on personal data;​
 
●​ The data controller is the entity (including public bodies) that uses personal data for its own purposes 
(i.e., for a practical goal or activity), determining the means (i.e., technical and organizational modalities) 
of such processing.​
 
 
 
 

 
 
For data processing to be lawful, it must comply with specific conditions, legal bases, and purposes set forth and 
permitted by current legislation. The main legal references concerning personal data protection are: 
●​ EU Regulation 2016/679 on the protection of natural persons with regard to the processing of personal 
data and on the free movement of such data (hereinafter: General Regulation or GDPR);​
 
●​ Italian Legislative Decree no. 196 of June 30, 2003, Personal Data Protection Code, as amended to 
comply with EU Regulation 2016/679 (hereinafter: Code).​
 
Providing information about data processing (also referred to as a privacy notice) is both a right of the data 
subject and an obligation of the data controller. In short, whether authorized by law or by the data subject's 
consent, the controller must inform the data subject beforehand about the purposes of processing, its legal 
basis, the types of data involved, retention periods, modalities, etc., in accordance with Articles 13 and 14 of the 
General Regulation. 
This notice refers to both Article 13 (personal data collected from the data subject) and Article 14 (data not 
obtained directly from the data subject), as the data is collected by the Clinical Trial Center and shared with 
other controllers who do not have direct contact with the data subject. 
2.​ Purpose and Legal Basis of Processing 
The purpose of data processing refers to the practical aim pursued. However, for the processing to be lawful, this 
is not sufficient. The legal basis refers to a legal condition which, when met, makes the purpose (and the related 
processing) lawful for a certain category of controllers. 
This processing is carried out for scientific study and research purposes. 
The primary legal basis is Article 9(2)(j) of the General Regulation (“processing is necessary for... scientific 
research purposes”) and, at national level, Article 110 of the Code (“Research in the medical, biomedical and 
epidemiological field”), according to the limitation clause in Article 9(4) GDPR. Since Article 110 of the Code 
usually requires the data subject's consent for research purposes, consent under Article 9(2)(a) GDPR is also a 
legal basis. 
Regarding obligations to document the research process and the oversight role of supervisory bodies, these are 
grounded in specific laws, and the corresponding legal basis is Article 9(2)(g) GDPR (“processing is necessary for 
reasons of substantial public interest”). 
3.​ Controllers, Processors, and Authorized Personnel 
The data controllers are all entities affiliated with the Ambrosia Consortium that, in their respective roles, share 
the research protocol and have accepted the purposes and modalities of data processing necessary for its 
implementation. 
 

 
Persons who carry out the processing under the authority of the data controller are defined as authorized 
personnel. According to Article 2-quaterdecies of the Code, the data controller may assign specific tasks and 
functions to natural persons working under their authority. The following are the entities and persons involved in 
the study: 
●​ Clinical Trial Center: Careggi University Hospital (AOU Careggi – Geriatrics Unit – UTIG), referred to as 
the “Clinical Trial Center”, with Prof. Stefano Fumagalli as the Principal Investigator;​
 
●​ Promoting Center: University of Florence (Department of Immunology and Microbiome), referred to as 
“UNIFI” or “Promoting Center”, with Prof. Amedeo Amedei;​
 
●​ Foundation Health Research Institute of the Balearic Islands, Palma de Mallorca, Spain – Dr. Gwendolyn 
Barceló-Coblijn;​
 
●​ Synbiotec Srl, Camerino, Italy – Prof. Maria Cristina Verdenelli;​
 
●​ Department of Agriculture, Food and the Marine (DAFM) – School of Agriculture and Food Science, 
University College Dublin – Dr. Marco Garcia-Vaquero;​
 
●​ Northumbria University, Newcastle upon Tyne, UK – Prof. Iain Brownlee;​
 
●​ Genevention GmbH, Göttingen, Germany – Dr. Thomas Lingner.​
 
If an external subject processes data on behalf of a controller (e.g., IT services), this requires a data processing 
agreement under Article 28 GDPR, and the subject becomes a data processor. A list of processors can be 
requested using the contact details of the Clinical Trial Center found at the end of this notice. 
4.​ Types of Data Processed 
This study involves processing the following personal data categories: 
●​ Special categories of personal data under Article 9(1) GDPR, particularly health-related data including 
clinical, functional, psychological, and laboratory test results.​
 
5.​ Processing Methods 
Providing personal data is essential to participate in the study. Refusal to provide such data will exclude 
participation. 
Authorized personnel from AOU Careggi may access identifying data, whereas authorized personnel from other 
data controllers will only access pseudonymized data. 
Pseudonymization means replacing direct identifiers (e.g., names) with codes, and securely storing the 
re-identification key separately. For example, a tax code, although encoded, is not pseudonymized under this 
 

 
definition and cannot be used. 
The pseudonymization process is carried out by AOU Careggi, which maintains a direct relationship with 
participants. It will record, process, and store personal data and biological samples with the associated code. 
Only AOU Careggi can re-identify participants. 
The code will be used in all communications with other data controllers instead of the participant’s name. 
Only the Clinical Trial Center has access to the original clinical documentation and the decoding key. All other 
parties receive only pseudonymized data. 
The legal basis for data communication among controllers is the participant’s consent. 
Data (pseudonymized) may be transferred to the United Kingdom, a third country not under EU law. However, 
the Clinical Trial Center and the Promoting Center ensure adequate safeguards based on EU Commission 
Implementing Decision (EU) 2021/1773. 
Participation implies that the Ethics Committee and National/International Health Authorities may access the 
original clinical data for compliance and monitoring, regardless of consent. 
A third party affiliated with UNIFI will perform study monitoring to ensure data quality. These subjects may 
access identifying data based on legal grounds and independently of participant consent. 
Health data will not be disclosed. Study results will be made public using aggregated, anonymous data (data 
that cannot be traced back to an individual). 
Both the Clinical Trial Center and Promoting Center will apply appropriate technical and organizational 
measures to protect personal data, dignity, and confidentiality. 
Processing will be carried out using paper and digital tools. The main study database, which stores the 
pseudonymized data, is located at the University College Dublin. 
6.​ Data Retention 
Personal data will be stored for ten (10) years after the conclusion of the study. 
Biological samples collected during the study (linked to pseudonymized data) will be stored for ten (10) years at 
the Laboratory of the Department of Experimental and Clinical Medicine at UNIFI. 
Data and samples may be used for related studies (i.e., studies that directly follow from the present one). In 
such cases, a new data processing notice will be published on the official AOUC and UNIFI websites. 
Outside these cases, all personal data will be deleted after the retention period. 
 
 

 
7.​ Exercise of Rights 
The data subject has the right to: 
●​ Access their personal data;​
 
●​ Request correction, supplementation, or, where applicable, deletion (with some exceptions);​
 
●​ Request restriction of processing (under Article 18 GDPR);​
 
●​ Object to data processing.​
 
A participant may withdraw from the study at any time. No further data will be collected after withdrawal. 
A participant may also request deletion of previously collected data. However, this right may be limited if data 
retention is legally required or if deletion would compromise the scientific integrity of the study. 
Requests to exercise these rights can be submitted to the Data Protection Officer (DPO) of AOU Careggi or the 
Principal Investigator, using the contact details below. 
If the data subject believes their rights are violated, they may file a complaint with the Italian Data Protection 
Authority (Garante) under Article 77 GDPR or seek legal redress under Article 79 GDPR. 
8.​ Contact Details 
Data Protection Officer (DPO): Paolo Tagliaferri​
 Tel: +39 055 7979067 | Mobile: +39 366 6823917​
 Email: rpd@aou-careggi.toscana.it 
Principal Investigator: Prof. Stefano Fumagalli​
 Email: stefano.fumagalli@unifi.it 
Supervisory Authority:​
 Garante per la Protezione dei Dati Personali​
 Website: www.garanteprivacy.it​
 Email: garante@gpdp.it​
 Phone: +39 06 696771 
 
 
 
 
 

 
DECLARATION OF CONSENT TO THE PROCESSING OF PERSONAL DATA​
 pursuant to the EU General Data Protection Regulation 2016/679 and Italian Legislative Decree 196/2003​
 Version 1 dated April 19, 2021 
Study title:​
 “Ambrosia” food strategy for preventing undernutrition and assessment of new biomarkers in older heart failure 
and atrial fibrillation patients.​
 AMBROSIA: “Microbiota-Inflammation-Brain axis in heart failure: new food, BiomarkerS and AI Approach for the 
prevention of undeRnutrition in Older Heart Failure and Atrial Fibrillation Patients”​
 Protocol code, version and date: Version 1 – April 19, 2021​
 Study Sponsor: Prof. Amedeo Amedei​
 Department of Experimental and Clinical Medicine​
 Laboratory of Immunology and Microbiome​
 University of Florence​
 amedeo.amedei@unifi.it​
 +39 0552758330​
 Principal Investigator: Prof. Stefano Fumagalli​
 Geriatrics Unit – UTIG, AOU Careggi and University of Florence​
 stefano.fumagalli@unifi.it​
 +39 0557949429 
I, the undersigned _____________________________________​
 born on ___ / ___ / _______ resident in ____________________________________________  street/square 
__________________________________________​
 Phone number _________________________________________​
 domicile (if different from residence) __________________________ 
●​ DECLARE​
 that I understand and explicitly accept that my personal data will be processed for this study in the 
manner described in detail in the Information on the processing of personal data in accordance with the 
General Regulation and the Code; 
●​ that I understand and explicitly accept that my pseudonymized personal data may be transferred to a 
recipient in a country outside the European Union (United Kingdom), where the General Data Protection 
Regulation does not apply; 
●​ that I understand and explicitly accept that if I withdraw my consent to participate in the study, no 
further personal data about me will be collected; 
●​ that I understand and explicitly accept that even after withdrawing my consent, the pseudonymized 
personal data previously collected may still be stored and processed solely for the purpose of meeting 
any legal obligations or to the extent that such data are essential for the conduct of this study and the 
achievement of its objectives; 
●​ that I understand and explicitly accept that for any questions regarding the protection of personal data 
processed for this study, I can contact the Data Protection Officer of the Trial Center, whose contact 
information is indicated in the information notice. 
 
 

 
 
I therefore declare to 
give my consent, pursuant to Art. 110 of the Code and Art. 9(2)(a) of the General Regulation, to the processing 
of my personal data for the purposes and in the manner described in the information sheet, which is part of this 
consent, and of which a copy was provided to me on the date: ___ / ___ / _______. 
 
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 Full name of legal representative                         Date                     Time  Signature  
If the patient, or the recognized legal representative, is unable to read: 
I have participated in the entire informed consent discussion for data processing. I certify that the information in 
the consent form or any other written information was explained thoroughly and was apparently understood by 
the patient or the recognized legal representative of the patient. Informed consent was freely given by the 
patient or the recognized legal representative. 
 
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