Ageing Gut Brain Interactions
Conditions: Dementia Alzheimers
Sponsor: University of Aberdeen

Version 3.0 28 February 2018 
 
 
 
 
 
 
 
Research Study Protocol 
 
Full Title: 
Ageing Gut-Brain Interactions 
Study Acronym: 
AGEING-GB  
Sponsor: 
University of Aberdeen 
 
Sponsor Reference Number: 
2/103/17 
Funder: 
Tenovus Scotland & NHS Grampian  
Chief Investigator: 
Professor Phyo Myint  
REC Reference Number: 
TBA 
R&D Reference Number: 
TBA   
ISRCTN / Clinical trials gov. No: 
Not applicable  
Version Number and Date: 
Version 3.0; 28 February 2018  
Co-Investigators: 
Prof Alex Johnstone 
Dr Alison Donaldson 
Dr Karen Scott 
Dr Emma Law 
Dr Roy L Soiza 
 
 
 
 
 
 
 
 
 
 

Version 3.0 28 February 2018 
 
Protocol Approval 
Ageing Gut-Brain Interactions Signatures 
By signing this document I am confirming that I have read, understood and approve 
the protocol for the above study. 
 
 
PHYO MYINT  
 
 
 
 
 
28 February 2018 
Chief Investigator 
 
Signature 
 
Date 
Professor Phyo Myint 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 3.0 28 February 2018 
List of Abbreviations 
 
 
AD 
Alzheimer’s Disease 
CRF 
Case Report Form 
CNORIS 
Clinical Negligence and Other Risks Scheme 
GCP 
 
Good Clinical Practice 
ISF 
Investigator Site File 
SCFA 
Short Chain Fatty Acid  
SMG 
Study Management Group 
SOP 
Standard Operating Procedure 
TMF/SMF 
Trial/Study Master File 
 
 
 

 
Version 3.0 28 February 2018 
 
 
Summary 
 
This research project will address a desperate need for evidence on how diet 
could be used to treat and improve symptoms of Alzheimer’s disease (AD). It has been 
estimated that 36 million people have dementia worldwide, and in older people 
Alzheimer's disease accounts for 60–70% of all dementia. Research supports the 
hypothesis that modifiable lifestyle-related factors are associated with cognitive decline, 
which opens new avenues for prevention or modification of disease.  
The concept that inspires this proposal ‘Ageing-Gut-Brain Interactions study’ is 
that our gut microbiota impact upon the gut-brain axis and thereby on behaviour, 
including challenging behaviours often associated with dementia. In the absence of 
available cures for Alzheimer's disease, diet is an important modifiable component but 
we currently have little knowledge about the role of diet in clinical symptoms of 
dementia. A recent study from Ireland from the European Union funded Nu-Age cohort 
reported that the gut microbiota profile in the elderly was different between community-
living and institutionalized individuals, with specific microbiome profiles correlating with 
frailty and poor health.  
Changes in dietary composition and diversity were considered the main drivers 
of the shifts in gut bacteria profile. In this multi-disciplinary research study, we will 
investigate the gut microbiota composition in people with Alzheimer’s dementia with 
challenging behaviours, test the feasibility of recruitment, and provide initial data to 
support a future grant application involving a dietary intervention study in patients with 
Alzheimer’s disease. 
We will test our hypothesis that the gut-brain axis promotes behavioural changes 
in Alzheimer’s dementia and is responsive to changes in gut microbiota profile, by 
comparing the gut microbiota profile between three participant groups (1) Alzheimer’s 
dementia with challenging behaviour, (2) Alzheimer’s dementia without challenging 
behaviour, and (3) a control group of healthy age-matched elderly. We will also carry out 
a survey to care homes to assess their willingness to participate in dietary 
supplementation study. 
 

 
Version 3.0 28 February 2018 
1.  
Introduction 
1.1. Background 
Healthy life expectancy is a key area of research. It has been 
estimated that 36 million people have dementia worldwide 
(Prince et al., 2013) and that there are 4.6 million new cases of 
dementia every year (Ferri et al., 2005). Epidemiological 
evidence supports the hypothesis that modifiable lifestyle-
related factors are associated with cognitive decline, opening 
new avenues for prevention (Solfrizzi et al., 2008). Alzheimer's 
disease is the commonest cause of dementia in older people, 
accounting for 60–70% of all dementia cases when using 
traditional diagnostic criteria for dementia subtypes (Blennow et 
al., 2006; Fratiglioni et al., 1999).  
There are no available cures for AD, but an alternative approach 
is to use strategies that delay disease progression at an early 
stage (Lobo et al, 2000). Optimal brain function results from 
highly complex interactions between numerous genetic and 
environmental factors, including food intake, physical activity, 
age and stress (Solfrizzi et al, 2008). Diet in particular has become 
the object of intense research in relation to cognitive aging and 
neurodegenerative diseases.  
The gut microbiota is a large, diverse collection of microbes, 
collectively containing 100 times more genes than the host. It is 
host-specific, contains heritable components, can be modified by 
diet, surgery or antibiotics, and in its absence nearly all aspects 
of host physiology are affected (Marchesi et al, 2016). We now 
realise that the human microbiota is a previously overlooked 
system that makes a significant contribution to human biology 
and development.There is a new and exciting field of research 
with limited published data in the elderly (Mariat et al, 2009; 
Claesson et al, 2012), that could provide a basis for the design of 
novel, microbiota-targeted, therapies to improve care of older 
people who suffer from Alzheimer’s dementia.  
There is increasing evidence that identifies the gut microbiota as 
a key conduit between nutrition and brain function (Goyal et al., 
2015). Reduction in the frequency of genes encoding short chain 
fatty 
acid 
(SCFA) 
production 
was 
prominent 
among 
institutionalized older adults, as were increases in circulating 
pro-inflammatory cytokines tumour necrosis factor-alpha, 
interleukins-6 and -8, and C-reactive protein (Claesson et al., 
2012). 
 
 
 

 
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1.1.                     
Rationale for Study 
 
Hypothesis: The composition and/or diversity of the gut microbiota is 
different between healthy elderly and those with Alzheimer’s dementia, 
who do or do not exhibit behaviour(s) that are challenging 
The concept that inspires Ageing-GB is that our gut microbiota impact upon 
the gut-brain axis and thereby on behaviour. We need to understand the 
nature of that impact, the underlying mechanisms, and how changes in diet 
can reprogram our gut microbiota-brain axis to resolve or reduce clinical 
symptoms associated with Alzheimer’s dementia.   
However, there has been no published work that we are aware of to 
examine the gut microbiota profile in patients with Alzheimer's disease. 
Consequently, first we need to demonstrate the differences in microbiota 
profile between AD patients with or without behaviours that are more 
challenging to manage. We believe that our work will be fundamental to 
provide evidence to support dietary modification or supplementation as 
cost-effective and safe avenues for alleviating signs and symptoms of 
dementia in this vulnerable group and thus reduce the carer burden.  
This study will require the co-operation of care home managers and staff, 
and will thus simultaneously assess the feasibility of performing a 
nutritional intervention study in this group of individuals, in this setting. 
 
 
2.  
Study Objectives and Outcomes 
2.1.  
Objectives 
2.1.1. 
Primary Objective 
 
To compare the composition and activity of the gut microbiota in three 
groups of elderly individuals: (i) Alzheimer’s dementia and challenging 
behavioural symptoms, (ii) Alzheimer’s dementia and no challenging 
behavioural symptoms, (iii) and people without dementia of any type.  
 
2.1.2. 
Secondary Objective 
 
To assess the willingness of care homes and carers to participate in a 
research trial investigating the links between diet and Alzheimer’s 
dementia. 
2.2.  
Outcomes 
2.2.1. 
Primary Outcome 
 
Differences in the composition and activity of gut microbiota between 
three groups.  
2.2.2. 
Secondary Outcome 

 
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The feasibility of undertaking a study with this group of elderly, vulnerable 
people in a care home setting including assessing the feasibility of the 
outcome of the future trial such as quality of life outcome. 
3.  
Study Design 
3.1.  
Study Description 
 
An observational case-controlled study with three groups of participants 
with 1:1:1 will be carried out. A total of 60 volunteers, 20 in each group 
from the following groups (i) Alzheimer’s dementia and challenging 
behavioural symptoms, (ii) Alzheimer’s dementia and no challenging 
behavioural symptoms, (iii) without any type of dementia, will be 
recruited from care homes.  
 
 
Each volunteer (assisted by staff) will provide two faecal samples, at 
least a week apart which will be analysed for microbial composition and 
activity by assessing Short Chain Fatty Acid profile (SCFA profile). Faecal 
samples will be collected using a pot on a toilet/commode, which will be 
sealed and processed in the laboratory within 12hr. 
 
Additional information on regular diet composition will be collected by 
accessing the weekly care home menu. Staff will observe participants 
and record every episode which requires staff intervention as a result of 
behaviours that are challenging to manage.  
 
A quality of life questionnaire will be completed by each volunteer in 
Alzheimer’s dementia groups using DEMQOL (Dementia Quality of Life 
questionnaire).  
 
DEMQOL is widely used patient reported outcome measures (PROMs) 
of health related quality of life in people with dementia.  
 
Finally, we will collect other information on medication, personal 
characteristics, co-morbidities etc. to mitigate any confounding effects. 
 
 

 
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To achieve the secondary objectives the following outcomes will be 
assessed. 
We will collect information on the following key aspects of feasibility of 
a larger study (future clinical trial) based on the main hypothesis driven 
work carried out under aim 3 described below 
(1) Proportion of eligible older people with Alzheimer’s dementia with 
or without challenging behaviours  
(2) Proportion of eligible participants willing to participate  
(3) Proportion of participants who are able provide samples in each 
group  
(4) Proportion of participants (staff who are looking after them or 
relatives) who are able to provide study data /information  
We will assess participants, their carers and whenever relevant 
managers and staff of care home and relatives/family members and 
people with Alzheimer’s dementia with regard to willingness to 
participate in a research trial and to identify issues to be addressed to 
gain support for such an intervention trial through end of study 
questionnaire conducted by the study research nurse face to face.  
This will explore the practical issues which need to be considered in the 
future study. A study completion questionnaire will be introduced after 
sampling is complete (Appendix B). 
 
 
 
 
 

 
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3.2.  
Study Matrix  
 
Components 
Objectives 
Tasks 
Case-control study 
Primary + 
Secondary 
See study matrix 
below 
Completion 
questionnaire 
Secondary  
See study matrix 
Appendix B 
Care home survey 
Secondary  
Appendix A 
 
 
Study Matrix for case-control study 
 
 
Measurements 
At enrolment 
(after consent) 
Week 1 
Week 2 
Demographics 
X 
 
 
Height 
X 
 
 
Weight 
X 
 
 
Co-morbidities 
X 
 
 
Medications 
X 
 
 
Mini Nutritional  
Assessment 
X 
 
 
Food Menu 
X 
 
 
Faecal Samples 
 
X 
X 
Behavioural chart 
X 
 
 
DEMQOL in AD groups 
X 
 
 
Completion 
exit 
questionnaire 
 
 
X 
 
 
4.  
Study Population 
4.1.  
Number of Participants 

 
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(i) with Alzheimer’s dementia and challenging behavioural symptoms 
(n=20) 
(ii) with Alzheimer’s dementia and no challenging behavioural 
symptoms (n=20) 
(iii) with no dementia (n=20) 
 
4.2.  
Inclusion Criteria 
 
Resident in a care home 
4.3.  
Exclusion Criteria 
 
1. Use of antibiotics in the last 8 weeks 
2. Active gastrointestinal disease. 
 
3. Unable to provide informed consent 
5.  
Participant Selection and Enrolment 
5.1.  
Identifying Participants 
 
Research nurse will perform the initial approach to local care homes to 
determine whether they are willing to be involved in the study. This will 
be done first by contacting care homes by telephone and follow up visit 
or post to the care home with the study information package. At this 
point the care home manager will be asked to identify individuals within 
each care home who may fall into one of the three study groups. These 
individuals (or their carer, legal guardian or person with power of 
attorney) will be approached to see if they are interested in participating 
in the study. If they were interested to speak to research team, then the 
research nurse will explain about the study and give study information 
for them to consider the study participation.  
 
5.2.  
Consenting Participants 
Consent will be taken by the study research nurse who has appropriate 
training. Consent will be recorded appropriately on the study consent 
form.  
 
For end of study questionnaire, participants’ consent will be taken 
specifically. 
 
 
5.3.  
Screening for Eligibility 

 
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In order to be recruited into study group (i) or (ii) there has to be an 
existing medical diagnosis of Alzheimer’s dementia that will be 
confirmed by cross-referencing with medical records. Likewise for 
recruitment to group (iii) no such diagnosis should exist. The sub-group 
stratification of Alzheimer’s dementia patients with or without 
behaviours that are challenging will be ascribed after speaking to care 
home staff and analysing care home records of participants. 
 
Eligibility will be determined based on the knowledge of care home 
manager and staff. At this stage, the research team will not have any 
knowledge of who they are. Potentially eligible participants will first be 
approached by care home manager/staff to enquire whether they 
would be willing to speak to research team. Only those who are willing 
to speak to research team will be approached by the research nurse and 
provide study information. If they are interested and provide permission 
to check the eligibility, the diagnosis will be checked against their care 
home records. In case if the care home staff deem the potential 
participant lacks capacity, formal capacity assessment will be carried out 
by medically trained research team member.  
 
Initial screening for eligibility will be carried out by care home staff and 
second level screening by study team will only happen after the 
participant has provided informed verbal consent prior to participation. 
If eligible written informed consent will be taken for study procedures.  
 
 
5.4.  
Ineligible and Non-Recruited Participants 
 
Only eligible volunteers will be recruited to the study, up to the required 
number in each group. Once this number is reached, any additional 
interested volunteers will be thanked for their interest. No data will be 
collected prior to recruitment.  
 
6.  
Withdrawal Procedures 
If any participant wishes to withdraw from the study at any point after 
recruitment, all data and samples collected will be destroyed. If the 
carer perceives that participation in the study is causing distress to the 
volunteer, they will provide advice but if the distress persists the 
volunteer may be withdrawn from the study. In both cases a ‘withdrawn 
from study’ form will be completed and attached to the CRF. Unless such 
a form is completed (by either the volunteer or their representative) and 
consent is thus withdrawn, all samples will be kept following 
appropriate study guidelines. As the study requires 20 participant in 
each arm of the study, we will replace the withdrawal with further 
recruitment. 
 
 

 
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7.  
Data Collection and Management 
7.1.  
Data Collection 
 
Faecal samples will be analysed for SCFA profile and DNA bacterial profile. 
Samples will be stored with anonymised labels for up to 10 years. The 
volunteer phenotype (informing the study group) will be recorded on the 
CRF. Consent will be sought from subjects to collect faecal samples. 
Samples from Aberdeen nursing homes will be collected to 
maintain/ensure sample quality and integrity. These will be collected from 
the care home by one of the research staff from the Rowett Institute. All 
food diaries and other questionnaires will be anonymised following 
recruitment, and stored in a locked filing cabinet in the care home 
manager’s office prior to collection by study researchers. Final storage will 
be locked filing cabinets in Human Nutrition Unit, or on a secure shared 
drive, accessible only by the researchers and auditors of the sponsor (for 
auditing purpose).  
7.2.  
Data Management System 
All data subsequently collected will be stored appropriately. 
Participants’ identities are strictly confidential. We will allocate a unique 
subject code for the individual participants and all the data will be 
recorded using this code. Only the research team will have access to 
participants’ full details, which will be saved on a shared drive with 
limited access on password-locked University computers. The hard copy 
will be stored in locked filing cabinet. 

 
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The CI will authorise and maintain adequate and accurate source 
documents designed to record all observations and other pertinent data 
for each subject. Data collection will be the responsibility of the CI in this 
study. Data will be recorded on paper CRFs, which will subsequently be 
entered onto a secure, password protected study database in SPSS 
format, by the research team. Electronic database will be held within 
University computer system in a shared study folder with restricted 
assessed to study team members and statisticians involved in the study 
who will be identified in study delegation log. All CRFs and original paper 
data will be safely stored in locked filing cabinet and researchers will be 
able to double check the raw data with the electronic file and original 
file. Database is owned by researchers and the Chief Investigator is the 
data controller.  Data will be entered twice for validation purpose. Data 
queries will be addressed by the research team members with specific 
statistical expertise. All University data were stored with a back-up. CRF 
data will be part of the database. Database may hold additional data 
collected from the questionnaire surveys; these will be in the form of 
separate sheets of data which will form complete database.  
Subjects will not be identified by name in the study database or on any 
study documents to be collected, but will be identified by a unique 
subject number. Source data are contained in source documents 
(original records). All the source data will be recorded in CRFs or original 
document form from research team. Data will be transferred into an 
electronic file and saved in password lock computer. All data will be 
transferred into an SPSS/Excel files as appropriate by the research 
nurse.  A copy of the CRF will remain at the Investigator’s site file at the 
completion of the study. 
Some of the samples will be sent, anonymously, to the bioinformatics 
team at the University of Aberdeen for final analysis. This means 
samples will be referred to by the unique study ID number. Any 
information collected by these third parties will utilise these coded 
details for all data output. Support provided by Statisticians from 
biomathematics and Statistics Scotland.  
 
8.  
Labs and Samples Analysis  
Level 5 laboratory at The Rowett Institute, University of Aberdeen will 
be where the faecal sample analysis will be conducted, under 
supervision of Dr Karen Scott. The samples will be analysed for short 
chain fatty acid profile (SCFA) and the bacterial DNA will be extracted 
for genome analysis. When the study is complete, the faecal samples 
will be destroyed.  

 
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8.1.  
The faecal/stool samples will be collected by inserting the sample 
collection container (pre-lined with two plastic bags, the inner one with 
holes) into the commode when the volunteer needs to defecate. The 
carer will separate the bags and store the sealed bag containing the 
faecal sample only in the sealed container and inform the lab that a 
sample is ready for collection. Samples will be transferred to the Rowett 
institute (University of Aberdeen) and stored in a -70 +/-5 OC freezer in 
a glycerol buffer for up to 2 weeks prior to DNA extraction. Extracted 
DNA will be further stored in a -70 +/-5 OC freezer in the Cat 2 grade lab 
until all volunteers finish the trial. All the samples will be anonymised. 
All freezers are calibrated and monitored by research team regularly. 
Final analysis (by the Bioinformatics team) will be done at the end of the 
study. 
 
After carrying out necessary tests, the samples will be destroyed as per 
sponsor’s regulations of disposing samples.  
 
9.  
Statistics and Data Analysis  
9.1.  
Sample Size Calculation 
 
We have examined existing data held at RINH with the statisticians from 
Biomathematics and Statistics Scotland (BioSS) on gut bacteria in faecal 
samples.  The power calculations indicate that with 20 volunteers on a 
controlled diet the sample will provide at least 90% power to detect 
shifts of 20% or more in SCFA and metabolites, and a difference of 45% 
or more in bacteria between groups. Previous studies have shown that 
such shifts are achievable in healthy and diseased patient groups.  
 
 
9.2.  
Proposed Analysis 

 
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Data will be analysed using SPSS (latest version available at the time of 
analysis). Data will be presented descriptively and comparisons will be 
made among 3 groups. Parametric and non-parametric statistical tests 
will be applied for normally and non-normally distributed data, 
respectively.  
 
Care home survey data will be analysed using descriptive analysis to 
estimate the secondary objectives. Textual data will be transcribed 
verbatim and themes will be derived using thematic analysis.  
 
Questionnaire data will also be transcribed verbatim and summarised 
based on emerging theme bases on experiences and views of 
participants (when able to provide consent), carers and family members.   
 
9.3.  
Missing Data 
 
The two time points in this study will be used to show consistency of 
microbial profiles within an individual. If there are missing data points 
then a reduced dataset of the double time points will be analysed, and 
an additional analysis of single time points will be made. Having double 
collection times from each individual will also test the feasibility of the 
collection process for the main study. We will collect menus from both 
weeks preceding sample collection in order to have some dietary record 
in the immediate run-up to sample collection. 
 
9.4.  
Transfer of Data 
 
All researchers on the study will have access to University of Aberdeen 
shared computing facilities where the data will be stored so there will 
be no data transfer between sites. Samples transferred from care homes 
to the laboratory will be in anonymised containers labelled with 
volunteer number. Hard copies of questionnaire data will be transferred 
directly from the care home to the office and not left in vehicles 
overnight.  For research team members who are not staff members of 
UoA will either have access through honorary contract or via data 
transfer agreement between UoA and their respective Institutions.  
 
The data will be used to apply for further grant application for 
subsequent study and for the publication purpose. The data will be 
stored for six years after the last publication as per the local guidance 
and for the purpose of audit.   
 
 
10. 
Trial/Study Management and Oversight Arrangements  
10.1. 
 
Trial/Study Management Group 

 
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The study will be co-ordinated by a Study Management Group (SMG), 
consisting of e.g. the grant holder (CI), co-PIs Prof Alex Johnstone, Dr 
Karen Scott and Dr Alison Donaldson and the Research Nurse (TBA). 
This group will have overall responsibility for conduct and running of the 
study.  
 
10.2. 
 
Trial/Study Management 
 
A Research Nurse  will oversee the study and will be accountable to the 
CI. The Research Nurse  will be responsible for checking the CRFs for 
completeness, plausibility and consistency. However, this remains the 
overall responsibility of the CI. Any queries will be resolved by the CI or 
delegated member of the study team.  
A study-specific Delegation Log will be prepared and will be kept in the 
Trial Management Site file. The delegation log will have information of 
detailed the responsibilities of each member of staff working on the 
study. This site-specific delegation log will be held by the care home 
manager and will only contain details of the individuals recruited to the 
study within that care home. The overall study master file will be held 
by the CI and this file will contain full details and CRFs of all the 
volunteers recruited. 
 
10.3. 
 
Trial/Study Steering Committee  
 
The SMG will oversee the conduct and progress of the study.  
 
10.4. 
 
Data Monitoring Committee  
 
The SMG will oversee study progress. It is not thought necessary to have 
separate groups for this with the relatively small study involved here. 
 
11. 
Inspection of Records  
12.1 
The CI shall permit study related monitoring, audits, and REC review. The 
CI agrees to allow the Sponsor or, representatives of the Sponsor, direct 
access to all study records and source documentation. 
 
12. 
Good Clinical Practice  
12.1. 
 
Ethical Conduct of the Study 

 
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The study will be conducted in accordance with the principles of good 
clinical practice (GCP). 
In addition to Sponsorship approval, a favorable ethical opinion will be 
obtained from the appropriate REC and appropriate NHS R&D 
approval(s) will be obtained prior to commencement of the study. 
 
12.1.1.  
Confidentiality 
 
All laboratory specimens, evaluation forms, reports, and other records 
will be identified in a manner designed to maintain participant 
confidentiality. All records will be kept in a secure storage area with 
limited access to study staff only. Clinical information will not be 
released without the written permission of the participant, except as 
necessary for monitoring and auditing by the Sponsor or its designee. 
The CI and study staff involved with this study will not disclose or use for 
any purpose other than performance of the study, any data, record, or 
other unpublished, confidential information disclosed to those 
individuals for the purpose of the study. Prior written agreement from 
the Sponsor or its designee will be obtained for the disclosure of any 
said confidential information to other parties. 
 
12.1.2.  
Data Protection  
 
The CI and study staff involved with this study will comply with the 
requirements of the Data Protection Act 1998 with regard to the 
collection, storage, processing and disclosure of personal information 
and will uphold the Act’s core principles. The CI and study staff will also 
adhere, if appropriate, to the current version of the NHS Scotland Code 
of Practice on Protecting Patient Confidentiality.  Access to collated 
participant data will be restricted to the CI and appropriate study staff. 
Computers used to collate the data will have limited access measures 
via user names and passwords. 
Published results will not contain any personal data that could allow 
identification of individual participants. 
 
12.1.3.  
Insurance and Indemnity 

 
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The University of Aberdeen is Sponsoring the study. 
 
Insurance –  
 
 The University of Aberdeen will obtain and hold a policy of Public 
Liability Insurance for legal liabilities arising from the study. 
 
 Where the study involves University of Aberdeen staff 
undertaking clinical research on NHS patients, such staff will hold 
honorary contracts with Grampian Health Board which means 
they will have cover under Grampian’s membership of the 
CNORIS scheme. 
 
Indemnity: The University of Aberdeen does not provide study 
participants with indemnity in relation to participation in the Study but 
have insurance for legal liability as described above. 
 
13. 
Study Conduct Responsibilities  
13.1. 
 
Protocol Amendments, Deviations and Breaches 
 
The CI will seek approval for any amendments to the Protocol or other 
study documents from the Sponsor, REC and the relevant NHS R&D 
Office. Amendments to the protocol or other study docs will not be 
implemented without these approvals.  
In the event that a CI needs to deviate from the protocol, the nature of 
and reasons for the deviation will be recorded in the CRF, documented 
and submitted to the Sponsor. If this necessitates a subsequent protocol 
amendment, this will be submitted to the Sponsor for approval and then 
to the appropriate REC and lead NHS R&D Office for review and 
approval.  
In the event that a serious breach of GCP is suspected, this will be 
reported to the Sponsor immediately using the form “Breach Report 
Form”.  
 
13.2. 
 
Study Record Retention 
 
Archiving of relevant study documents will be authorized by the sponsor 
at the end of the study. Essential documents will be archived for a 
minimum of 6 years after completion of the study. Documents which are 
not to be archived will be destroyed (with authorization from the 
sponsor). Study documents will be archived in line with the sponsor SOP 
in the Health Sciences Building archive. UoA. Prior to archiving, during 
the study, material will be stored in locked filing cabinets, located in 
archive room in Human Nutrition Unit at the Rowett Institute. 
 

 
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13.3. 
 
End of Study 
 
The end of study is defined as collection and processing of the last 
sample from the last volunteer. The Sponsor, CI and/or the TMG have 
the right at any time to terminate the study for clinical or administrative 
reasons.  
The end of the study will be reported to the Sponsor and REC within 
90 days, or 15 days if the study is terminated prematurely. The CI will 
ensure that any appropriate follow up is arranged for all participants. 
A summary report of the study will be provided to the Sponsor and REC 
within 1 year of the end of the study. A summary brief will also be 
provided to all participating care homes. 
 
14. 
Reporting, Publication and Notification of Results  
14.1. 
 
Authorship Policy 
 
Ownership of the data arising from this study resides with the study 
team and their respective employers. On completion of the study, the 
study data will be analyzed and tabulated, and a clinical study report will 
be prepared.  
 
14.2. 
 
Publication 
 
The clinical study report will be used for publication and presentation at 
scientific meetings. Investigators have the right to publish orally or in 
writing the results of the study. 
Summaries of results will also be made available to Investigators for 
dissemination within their clinical areas (where appropriate and 
according to their discretion). 
 
14.3. 
 
Peer Review 
 
This project has received funding from Tenovus Scotland and the NHSG 
Endowment fund, and has thus been peer reviewed by both funders. It 
has also been reviewed by the Rowett Human studies management 
group prior to submission to funders.  
 

 
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composition correlates with diet and health in the elderly. Nature 2012 Aug 
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 Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, et al. Prevalence of 
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