The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses
Phase: NA
Conditions: Obesity
Sponsor: Imperial College London

 
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< Version 3, 18/11/2015> 
 
Study Management Group 
Chief Investigator:  
Gary Frost 
Co-investigators:  
Shatha Alrabiah 
Statistician:  
 
Shatha Alrabiah 
Study Management:  Gary Frost 
 
Sponsor: Joint Research Compliance Office 
Imperial College London and Imperial College Healthcare NHS Trust 
5th Floor, Lab Block, Charing Cross Hospital 
Fulham Palace Road, London, W6 8RF 
Tel: 0203 311 0204  Fax: 0203 311 0203 
Funder: Royal Embassy of Saudi Arabia-Cultural Bureau in London (King Saud bin Abdul-Aziz 
University for Health Sciences) will be funding this study. 
Tel: +44 (203) 249 7000 
 
STUDY PROTOCOL 
The Acute Effects of Food Structure on Appetite 
Regulation 

 
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This protocol refers to the study ‘The acute effects of food structure on appetite 
regulation’ and presents information about procedures for recruiting human participants.  
Problems related to this trial should be referred to Professor Gary Frost: 
g.frost@imperial.ac.uk 
This study will adhere to the principles outlined in the NHS Research Governance 
Framework for Health and Social Care. It will be conducted in compliance with the protocol, 
the Data Protection Act and other regulatory requirements as appropriate.  
Protocol authorized by: 
Professor Gary Frost, 
Professor of Nutrition and Dietetics, 
Department of Investigative Medicine, 
Hammersmith Hospital Campus, Imperial College, 
6th Floor, Commonwealth Building, 
Du Cane Road, London, 
W12 0NN 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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GLOSSARY OF ABBREVIATIONS  
 
CCK                  Cholecystokinin          
GLP-1 
    Glucagon-Like Peptide 1 
PYY  
    Peptide YY 
VAS                  Visual Analogue Scale  
NIDDM             Non-insulin-dependent diabetes mellitus  
 
 
 
 
 
 
 
 
 
 
 
 

 
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CONTENTS 
 
1. STUDY SUMMARY 
 
2. INTRODUCTION 
Rationale 
Hypothesis 
Aim 
 
3. OBJECTIVES AND OUTCOME MEASURES 
 
4. STUDY DESIGN 
 
5. PARTICIPANT ENTRY 
Recruitment 
Inclusion and Exclusion Criteria 
Screening 
Withdrawal Criteria 
Participant Reimbursement 
Power Calculation 
Randomisation 
 
6. DIETARY INTERVENTION 
 
7. ADVERSE EVENTS 
 
 

 
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8. STUDY STRUCTURE 
 Solid meal group. 
 Milled (intact-cell) meal group. 
 Milled (destroyed-cell) meal group. 
 Assessments of gastric emptying – this will be carried out by adding 1500mg of 
paracetamol to the test meal. Levels will be measured at all time-points.  
 Assessment of gut hormones – we will measure ghrelin, CCK, PPY. GLP-1. 
 Assessment of appetite – this will be completed using visual analogue scale (VAS) 
followed by a meal given in excess at 180 minutes.   
 
 
9. APPENDIX 1: Blood Sampling Schedule  
      
10. STATISTICS AND DATA ANALYSIS 
 
11. REGULATORY ISSUES 
 
12. REFERENCES 
 

 
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1. SUMMARY OF STUDY 
 
TITLE: 
The Acute Effects of Food Structure on Appetite Regulation. 
 
AIMS: To investigate the effects of different food structures on appetite signals from the 
upper gastrointestinal tract. 
 
 
DESIGN:    A randomised, controlled, clinical trial.   
 
POPULATION: 
Healthy adults (no diagnosed diseases) aged between 18 and 65 
years. 
 
INTERVENTION:    Solid meal group. 
                                Milled (intact-cell) meal group. 
                                Milled (destroyed-cell) meal group. 
All of which contain the same foods (chickpeas, carrots, sesame oil, and apple) 
 
DURATION: One day on four occasions. 
 
 
 
OUTCOME MEASURES:   
 Difference in gastric emptying rate 
 Difference in appetite regulatory hormones (CCK, PYY, GLP-1 and ghrelin) levels 
and release time  
 Difference in energy intake at a given ad-libitum meal 
 Difference in appetite regulation as measured by VAS 
 
 

 
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2. INTRODUCTION 
The prevalence of overweight and obesity in adults in the European Union Countries was 
estimated to be 30-70% and 10-30%, respectively. This epidemic is rising in infants and 
children as well; over 60% of children are overweight (The Obesity Epidemic, CDC, 2011; 
WHO Europe, 2007). There is a substantial evidence that obesity signifies a burden on 
healthcare systems in developed and most developing countries, a dramatic increase in the 
incidence of coronary heart diseases, hypertension, cancer, and diabetes has been linked 
to obesity, in fact, obesity has become a main risk factor of many non-communicable 
diseases (WHO headquarters, 2010; Reilly, 2003; Mokdad, 2003; Bray, 2004).   
The challenge with modern dietary regimens is that they largely comprise meals that 
provide a poor sense of satiety. Appetite plays a crucial role in regulating energy balance 
and glucose haemostasis. Hunger sensation and appetite are mainly regulated by a number 
of gut hormones that function in either stimulating appetite or suppressing it. Traditionally, 
macronutrient content has been responsible of the release of these appetite-regulatory 
hormones. however here is little work on food structure. Structure of food is customarily 
referred to its appearance and texture of food (Lundin et al, 2008). 
Humans have developed very efficient methods to ensure maximal nutritional intake, 
leading to health problems in today’s society where energy and nutrient dense food is 
readily available. Food consumed by our ancestors (hunter gatherers), were rich in 
unprocessed fish, meat, vegetables, fruit, fungi and nuts. These foods therefore had many 
intact structural elements which control the release of nutrients (Jew et al, 2009; Frassetto 
et al, 2009). Recent work has shown that almonds are resistant to digestion and only 
release about 60% of their calorific content, due to the resistance to digestion of plant cell 
walls (Mori et al, 2011). It is likely that these nutrients are released slowly as the structures 
are gradually digested. This slow release of nutrients helps maintain satiety due to nutrient 
status and prolonged release of gut hormones (Jonsson et al 2010). Therefore, to maintain 
a healthy energy and glucose homeostasis, we need to consume foods capable of 
regulating gut hormone release. This project aims to explore the impact of food structure on 
appetite regulation. 
 
Rationale  
There is very little evidence at the present time in the role of food structure in energy 
homeostasis.  There is circumstantial evidence that foods consumed intact have great 
effects on suppressing appetite.            
 
 
 
         

 
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Hypothesis 
Cell wall structure will influence appetite and subsequent energy intake independent of 
nutritional content. 
 
Aim 
To test the effect of three structurally-different meals with the same nutritional content and 
volume on appetite regulation.  Each participant will receive the following meals: 
o Solid meal group. 
o Milled (intact-cell) meal group. 
o Milled (destroyed-cell) meal group. 
 
 All of which will contain the same macro and micro nutrients from the same food 
sources.  
 
3. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives  
 
1- To measure gastric emptying rate after each meal 
2- To measure and compare hunger, satiety and palatability, individually 
3- To investigate energy intake at a meal given in excess 
4- To investigate differences in gut hormones levels and release time – ghrelin, CCK, PPY 
and GLP-1 with each test-meal 
 
Primary outcome measure 
A decrease in energy intake at a meal given in excess between the solid and puree meal.   
Secondary outcome measures 
 Variance in gastric emptying rate as measured by Paracetamol plasma levels. 
 Difference in gut hormones levels. 
 Change in hunger and palatability as measured by VAS.  

 
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4. STUDY DESIGN  
This will be a randomised, controlled clinical trial of a dietary intervention comparing three 
structurally different meals investigated separately over one day. The study will be carried 
out on four separate occasions one week apart. Participants will be recruited from a variety 
of settings including hospitals, universities. The inclusion and exclusion criteria are outlined 
in details in table 2 below. The aim is to recruit 15 participants for this study that meet the 
inclusion recruitments and deemed fit for the study. All participants will be offered £25 for 
each completed study visit, plus transportation to and from the research unit.   
This randomised, controlled clinical trial of a dietary intervention will performed at the 
hospital’s research unit under the supervision of the researcher. No doubt that a hospital-
based investigation on food intake has its respective limitation; however, factors impacting 
on food intake are taken under account and minimised. The impact of a laboratory/hospital-
based investigation came to light as several researches have explored the impact of 
surroundings on an individual’s food intake. In addition to the impact of social surroundings 
and home environment, sensory factors such as visual, olfactory, auditory, and textual also 
influence individual’s food intake (Dupertuis et al 2003; Stroebele et al 2004). These factors 
are shown to have an impinging potential to alter motivation, mood, and behaviour of an 
individual and hence impact on food intake (Stroebele et al 2004). Therefore to minimise 
any disturbance to the individual’s normal food intake, an initial “dummy” visit to allow the 
subject to become familiar with the surrounding and despite given a restricted and 
controlled dietary intervention no records of food intake will be taken. Additionally, the 
environment of the research unit is also adjusted to mimic a home environment as much as 
possible. It is designed as a home-style living room that comprises of small dinning tables, 
chairs, TV, and iPads. The research unit will not only host our participants but also other 
participants from different studies within the research department. This is a positive addition 
to our study as it will enhance the social interaction and minimise the hospital-environment 
impact on normal food intake.   
The four phases that our participants undergo will include dummy-meal phase, solid-meal 
phase, Milled (intact-cell) meal and Milled (destroyed-cell) meal phase. Each phase is to be 
investigated separately one week apart from each other. In order to maintain a controlled 
variable in this study, the same controlled dietary intervention will be introduced during each 
phase however in different structural format. My proposed plan is to start with the trial-meal 
phase, then participants will go through simple randomisation to start with the solid-meal 
phase, then the puree meal phase, or vice versa.   
 
Table (1) outlines the dietary content that will be introduced to the participants at every 
phase. The portion size, weight, and calorific value are included within the table and this will 
remain constant throughout the different phases and throughout the study. This is to ensure 
that a constant variable is controlled and data retrieved from the study are comparable and 
unbiased.  

 
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Each meal form will consist of standard breakfast (table 1) then a lunch given in excess. 
 
Portion 
Weight (gram) 
Calories 
Chickpeas (boiled) 
200 
325 
Sesame oil 
13.6 
120 
Apple   
180 
90 
Total 
493.6 
570 
                                                                                                                                          
Table1: Test-meal content 
_________________________________________________________________________ 
 
 
5. PARTICIPANT ENTRY  
Recruitment 
Study advert posters will be placed in hospitals and universities with contact details. 
 
Inclusion and Exclusion Criteria 
Table (2) explains the inclusion and exclusion criteria that were considered in participants’ 
recruitment. 
 
 
 
 
 
 
 
 
 

 
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Table 2. INCLUSION AND EXCLUSION CRITERIA 
Inclusion Criteria 
Exclusion Criteria 
Gender: male and female 
Age ≥ 18 years ≤ 65 years 
Normal weight as classified by BMI 20- 
29.9 kg/m2  
Healthy, not diagnosed with any chronic 
diseases. 
Assessed as appropriate for inclusion, 
based on the pre-study screening. 
Willingness and ability to understand, 
participate and to comply with the study 
requirements  
Willingness and ability to give written 
informed  consent  
 
Any one who: 
Has thyroid defects 
Under hormone or steroids therapy  
Is pregnant or lactating (female) 
Had given birth within the past year 
(female) 
Is taking drugs that could affect appetite 
or plasma glucose levels.     
Is taking natural remedies that modulate 
appetite or plasma glucose levels. 
Has excessive alcohol intake 
Had blood donation within 12wks prior to 
start date 
Psychiatric illness 
Smokers 
History of any disease with unknown 
outcome 
Has diabetes 
Has nut allergy 
 
Screening 
Participants’ inclusion will be based on two screening phases, the first phase is telephone 
screening, where we take initial information to identify participants who fit our criteria, if so 
the participant will be asked to visit the facility for a screening visit that will last 
approximately one hour for each participant. See Box 2 for information that will be gathered 
in the screening visit.       
Once medical history, biochemistry, and anthropometric measurements have confirmed 
participant eligibility, a 7 days food-diary will be given to the participant to be completed the 
week prior to attending the first study visit (dummy visit) and prior to each subsequent visits. 

 
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This will allow us to form a more in depth assessment of the participant nutritional intake 
and dietary preferences. 
 
 
BOX. 2 SCREENING INTERVIEW DATA COLLECTION 
 Informed consent: requested and given 
 Personal details: name, address, telephone number, gender, date of birth, 
demographical data 
 Anthropometry: weight, height, calculation of BMI 
 Medical history: current medications, allergies/drug reactions, past medical 
history [no prior CVD event, IBD], operations/surgeries, use of natural remedies 
and/or supplements, blood donation 
 Blood pressure 
 ECG: to record electrical activity of the heart   
 
 Blood tests: 
 Glycaemic control: HbA1c 
 CVD risk: blood tests: lipid profile [total cholesterol, HDL-cholesterol, LDL-
cholesterol, triglycerides]    
 Renal function: urea and electrolytes (sodium, potassium, chloride and 
bicarbonate), creatinine, estimated glomerular filtration rate 
 Liver function: alanine transaminase, aspartate aminotransferase, alkaline 
phosphatase, albumin, total protein, bilirubin. 
 Female participants: questioned on pregnancy in past year, current pregnancy 
status lactation. 
 
 
Withdrawal Criteria  
 Significant deviation from the approved protocol 
 The participant no longer fits the inclusion criteria 
 Pregnancy (female) 

 
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 The participant withdraws consent 
 
Participant Reimbursement  
All participants will be offered £25 for each study visit plus transportation to and from the 
research unit. This does not include screening visits.                                                             
If a participant withdraws from the study at any point, they will be reimbursed for the part 
they completed.   
Power Calculation  
We aim to detect a variance of 200kcal in energy intake with a SD of 220kcal, based on a 
previous trial by Batterham (2003). Assuming a power of 90% and alpha of 0.05 we will 
require a sample of 15 subjects. 
 
6. DIETARY INTERVENTION 
All subjects will receive four different meals that contain the same components served in 
different forms (Solid, Milled (intact-cell), Milled (destroyed-cell)). These will be 
commercially available food items. As for the dummy visit, the participants will be given a 
standardized solid meal with the same components as the other test meals.  
7. ADVERSE EVENTS  
Definitions  
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study 
subject.  
  
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or 
effect that: 
·         Results in death 
·         Is life-threatening – refers to an event in which the subject was at risk of death at the 
time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe 
  
·         Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
·         Results in persistent or significant disability or incapacity 
·         Is a congenital anomaly or birth defect 

 
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Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death 
or hospitalisation but may jeopardise the subject or may require intervention to prevent one 
of the other outcomes listed in the definition above, should also be considered serious. 
  
Reporting Procedures 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.  
  
Non serious Adverse Event  
All such events, whether expected or not, should be recorded.  
  
Serious Adverse Event  
An SAE form should be completed and faxed to the Chief Investigator within 24 
hours.  However, relapse and death due to chronic conditions and hospitalisations for 
elective treatment of a pre-existing condition do not need reporting as SAEs. 
  
All SAEs should be reported to the xxx REC where in the opinion of the Chief Investigator, 
the event was: 
·         ‘related’, ie resulted from the administration of any of the research procedures; and 
·         ‘unexpected’, ie an event that is not listed in the protocol as an expected occurrence 
  
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP 
studies.  The Chief Investigator must also notify the Sponsor of all SAEs. 
  
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
  

 
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Contact details for reporting SAEs 
Fax:  020 8383 8320 attention Gary Frost 
Please send SAE forms to: G.Frost@imperial.ac.uk 
Tel: 07872850308 (Mon to Fri 09.00 – 17.00) 
  
8. STUDY STRUCTURE 
Following successful completion of screening phase, participants will go through four 
phases. The same course of action will take place in all four phases of the study; once the 
participant arrive to the CRF unit, the participant will be asked to step into the bioelectrical 
impedance machine to measure their weight, height, and body fat percentage. After that a 
cannula will be placed into the participant's arm to take blood samples starting from 10 
minutes prior to the test meal. The participant will also be asked to do a visual analogue 
scale to measure satiety and hunger. Next blood sample will take place 10 minutes later 
along with introducing the test meal. The participant will be asked to consume the test meal 
within 10 minutes. Blood samples will take place subsequently at 15, 30, 60, 90, 120, and 
180. This will make up a total of 110mls blood samples drawn. The cannula will be removed 
at this point, then an open buffet homogeneous pasta meal will be introduced to the 
participant to eat comfortably.      
The first visit will be a dummy-visit, for the purpose of familiarizing the participant with the 
new ambience. After the dummy visit, participants will be randomly allocated (using a 
computer randomization program) to one of the three test meals on each visit; ‘solid’, 
‘milled-destroyed cell’ or ‘milled-intact cell’ meal. Hence each participant will be through all 4 
phases by the end of the fourth study visit. Participants will be instructed to avoid strenuous 
exercise, caffeine, and alcohol on the day prior to each study day. See Figure 1 for a 
detailed overview of the whole study design. 
 
 
 
 
 
 
 

 
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Figure 1: Schematic Representation of Study period 
 
 Biochemistry:  All visits will take place in the NIHR/Welcome Trust Imperial CRF. 
Fasting blood samples (110 ml) will be taken during the screening visits. During the 
study visits, a total of 110ml blood samples will also be taken to measure the following 
parameters: insulin, glucose, PYY, CCK, ghrelin, GLP-1 and paracetamol levels.  
Assays for routine bloods will be performed by the Department of Chemical Pathology at 
Imperial College Healthcare NHS Trust.  Assays for gut hormones will be performed at 
Imperial College London, Hammersmith Site.  
 Gastric emptying rate: to measure gastric emptying rate the participant will be given 
1500mg of Paracetamol with the test meal, then plasma levels will be measured at each 
time point, see figure 2. Paracetamol administration will be carried out by a qualified 
researcher from the research unit.   
 
Screening 
Visit 1: 
Dummy 
visit 
Visit 2 (Solid 
meal) or 
(milled DC 
meal) or 
(milled IC 
meal) 
Visit 3 (Solid 
meal) or 
(milled DC 
meal) or 
(milled IC 
meal) 
Visit 4 (Solid 
meal) or 
(milled DC 
meal) or 
(milled IC 
meal) 

 
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Fig 2. Schematic representation of appetite study activities  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Food Diaries Record and Analysis: Participants will be required to keep a food diary 
throughout the study period, although they will be required to record their dietary intake 
for 7 days before each study visit only.  This will allow for a comparison of energy and 
macronutrient intake.  The diaries will be analysed using dietary analysis software.   
 
 
 
 
 
 
 
 
 
 
 
 
Time (min) 
-10 
0 
15 
30 
60 
90 
120 
180 
 
Blood 
x 
x 
 x 
 x 
 x 
 x 
 x 
 x 
 
VAS 
x 
   
 x 
 x 
 x 
 x 
 x 
 x 
  x 
 
Cannula Insertion  
Cannula Removal  
 
 
Test meal + 1500mg paracetamol 
 
Ad-libitum meal 

 
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Appendix 1: Blood Sampling Schedule for the investigation 
 
 
 
 
Time 
PYY  
GLP-1 
CCK 
Ghrelin 
Glucose 
Insulin   
Paracetamol 
VAS 
 
-10 (1) 
600 µl 
400 µl 
1000 µl 
450 µl 
500 µl 
500 µl 
500 µl 
+ 
Breakfast 
0 (2) 
600 µl 
400 µl 
1000 µl 
450 µl 
500 µl 
500 µl 
500 µl 
 
 
15 (3) 
600 µl 
400 µl 
1000 µl 
450 µl 
500 µl 
500 µl 
500 µl 
+ 
 
30 (4) 
600 µl 
400 µl 
 
 
 
 
 
+ 
 
60 (5) 
600 µl 
400 µl 
1000 µl 
450 µl 
500 µl 
500 µ 
500 µ 
+ 
 
90 (6) 
600 µl 
400 µl 
 
 
 
 
 
+ 
 
120 (7) 
600 µl 
400 µl 
1000 µl 
450 µl 
500 µl 
500 µl 
500 µl 
+ 
 
180 (8) 
600 µl 
400 µl 
1000 µl 
450 µl 
500 µl 
500 µl 
500 µl 
+ 
Cannula removed 
 
 
 
 
 
 
 
 
 
Ad Libitum Meal 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
+ 

 
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9. STATISTICS AND DATA ANALYSIS  
 
Once all the required data is collected, statistical analysis will be completed by Microsoft 
Excels software, using ANOVA test.  
 
10. REGULATORY ISSUES  
 
Safety and Protection of Participants 
National Institute for Health Research/Wellcome Trust Imperial CRF provides a safe 
environment for all studies that take place in the unit. The safety of all participating subjects 
is ensured by a well-trained staff and qualified researchers. This study will only include 
healthy volunteers, so the risk is limited to bruising from cannula insertion, and the 
possibility of blood loss, which will be taken into consideration in the screening phase. 
Participants who gave blood during the three months prior to the start date will be excluded. 
 
Ethics Approval 
(The Chief Investigator has obtained approval from the XXXX Research Ethics Committee.   
The study will be submitted for Site Specific Assessment (SSA) at each participating NHS 
Trust.  The Chief Investigator will require a copy of the Trust R&D approval letter before 
accepting participants into the study.  The study will be conducted in accordance with the 
recommendations for physicians involved in research on human subjects adopted by the 
18th World Medical Assembly, Helsinki 1964 and later revisions.   Any amendments to the 
protocol will be approved by the sponsor, prior to being submitted to ethics.  On receiving 
ethical approval, all amendments will need further Trust R&D approval, before they can be 
implemented at any Trust site.) 
 
 
Consent  
A consent form must be sought to each participant who enters the study, after providing 
them with a detailed explanation of the study plus an information leaflet including the 
purpose and the entire stages of the study. Signed consent should be obtained. All subjects 
have the right to refuse to take place in the study without giving any reasons. After the 

 
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participant has entered the study the clinician remains free to give alternative treatment to 
that specified in the protocol at any stage if he/she feels it is in the participant’s best 
interest, but the reasons for doing so should be recorded. In these cases the participants 
remain within the study for the purposes of follow-up and data analysis. In case a 
participant wants to withdraw at any point they will have the right to do that without giving 
reasons.  
 
Confidentiality  
The chief investigator of the study will preserve confidentiality of all subjects participating in 
the study and is registered under the Data Protection Act. Personal information and contact 
details of subjects will be exposed only to the researchers. All the data will be recorded 
anonymously in the university computers without any personal data. Subjects’ personal 
data will only be kept on NHS computers, which are password required. Each participant 
will be assigned to an individual code will be used to identify the participant during the entire 
duration of the study, including lab blood analyses handling, and the data analysis 
afterwards, same confidentiality guidelines will apply to these individual codes. Data 
analysis will take place in the MRC Clinical Science Centre and investigative Medicine. The 
department provides a secure setting for keeping confidential information and data under 
the authority of Professor Gary Frost.   
 
Indemnity  
(Imperial College London holds Public Liability (“negligent harm”) and Clinical Trial (“non-
negligent harm”) insurance policies which apply to this study.  Imperial College Healthcare 
NHS Trust holds standard NHS Hospital Indemnity and insurance cover with NHS Litigation 
Authority for NHS Trusts in England, which apply to this study.  In addition, volunteers are 
registered as patients so that they have a right to all the associated health benefits this 
confers. Therefore, in addition to the Imperial College "no fault" indemnity scheme, normal 
NHS indemnity rules will apply) 
 
Sponsorship   
Imperial College London will be the main sponsor of this study.  
 
Funding  
Royal Embassy of Saudi Arabia-Cultural Bureau in London (King Saud bin Abdul-Aziz 
University for Health Sciences) will be funding this study. 
 

 
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Audits  
The study may be subject to inspection and audit by Imperial College London under their 
remit as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS 
Research Governance Framework for Health and Social Care (2nd edition).

 
- 22 -
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5. Global Status Report on Noncommunicable Diseases 2010. WHO headquarters, 2010. 
 
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7. Childhood obesity surveillance in the WHO European Region. WHO/Europe, 2007. 
 

 
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