Identifying Physiological Biomarkers for Monitoring Dietary Behaviours
Phase: NA
Conditions: Energy Intake, Metabolism, Digestion, Wearables, Dietary Intake Assessment, Healthy Volunteers, Blood Glucose
Sponsor: Imperial College London

Imperial College of Science, Technology and Medicine 
 
 
Page 0 of 14 
 
 
 
2024 
Identifying Physiological 
Biomarkers for Monitoring 
Dietary Behaviours 
NCT NUMBER: TBD 
16-JAN-2024 

 
 
FoodSense Study Protocol 
Version 5_Date 16/01/24 
IRAS ID: 333281  
 
 
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FoodSense Study 
 
 
 
 
Identifying physiological biomarkers for monitoring dietary 
behaviours 
 
 
 
 
 
Version 5_Date 16012024 
 
 
 
 
MAIN SPONSOR: Imperial College London 
                                                     FUNDERS: Imperial College London 
 
IRAS Project ID: 333281 
REC reference: 23/PR/1379 
 
 
 
 
 
 
 
 
 
 

 
 
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Study Management Group 
 
Chief Investigator: Dr Mingzhu Cai 
 
Co-PI: Dr Mayue Shi 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr Mingzhu Cai who will direct the query to the 
appropriate person. 
 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further 
information regarding the sponsorship conditions, please contact the Head of 
Regulatory Compliance at: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 1862 
Imperial College - Research Governance and Integrity Team (RGIT) Website 
 
Funder 
 
This study is funded by Dame Julia Higgins Postdoc Collaborative Research Fund. 
 
 
 
 
This protocol describes the FoodSense study and provides information about procedures for entering 
participants.  Every care was taken in its drafting, but corrections or amendments may be necessary. 
These will be circulated to investigators in the study.  Problems relating to this study should be referred, 
in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and Social Care 
Research. It will be conducted in compliance with the protocol, the Data Protection Act and other 
regulatory requirements as appropriate.  
 
 
 
 
 
 

 
 
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Table of Contents                                                             Page No 
1. 
INTRODUCTION 
5 
1.1. 
BACKGROUND 
5 
2. 
RATIONALE FOR CURRENT STUDY 
6 
3. 
STUDY METHDOLODY  
6 
3.1. 
PARTICIPANTS 
6 
3.2. 
RECRUITMENT 
6 
3.3. 
STUDY DESIGN 
6 
3.4. 
STUDY OUTCOME MEASURES 
8 
4. 
INCLUSION/EXCLUSION CRITERIA 
8 
4.1. 
INCLUSION CRITERIA 
8 
4.2. 
EXCLUSION CRITERIA 
8 
4.3. 
WITHDRAWAL CRITERIA 
8 
5. 
ADVERSE EVENTS 
9 
5.1. 
DEFINITIONS 
9 
5.2. 
REPORTING PROCEDURES 
9 
6. 
ASSESSMENT AND FOLLOW-UP 
10 
7. 
DATA STORAGE 
10 
8. 
REGULATORY ISSUES 
10 
8.1. 
ETHICS APPROVAL 
10 
8.2. 
CONSENT 
10 
8.3. 
CONFIDENTIALITY 
11 
8.4. 
INDEMNITY 
11 
8.5. 
SPONSOR 
11 
8.6. 
FINANCE 
11 
8.7. 
AUDITS 
11 
9. 
STUDY MANAGEMENT 
12 
10. 
PUBLICATION POLICY 
12 
11. 
REFERENCES 
13 
 
 
 
 

 
 
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KEYWORDS 
Diet, health, food intake, sensors, 
 
 
STUDY SUMMARY 
 
TITLE Identifying physiological biomarkers for monitoring dietary behaviours 
DESIGN Feasibility study/ Basic science study involving procedures with human 
volunteers 
AIMS 
 
Investigating physiological changes during eating behaviours. 
 
Identifying physiological biomarkers for dietary behaviours and 
glycaemic outcomes. 
 
OUTCOME MEASURES The primary outcome is the physiological features associated with dietary 
events (pre- vs post- meal). 
Secondary outcomes include: 
 Physiological and motor features associated with energy intake 
(high vs. low calorie meals). 
 Physiological and motor features associated with glycaemic 
biomarkers, including blood glucose, insulin and hormonal levels 
 
POPULATION Healthy adults 
ELIGIBILITY Subjects aged 18-65 years with BMI of 18-30 kg/m2 and no significant health 
problems. 
DURATION Each participant will participant in two 2-hour study visits within up to 8 weeks 
 
 
 
 
 
 
 

 
 
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1. INTRODUCTION  
 
1.1. 
BACKGROUND 
 
Assessing dietary intake across populations is a fundamental challenge in nutrition 
research. Traditional dietary assessment methods, such as food diaries, rely on self-
reporting of individuals and suffer from poor accuracy and recall bias. Food records 
are estimated to cause 11-41% underestimations for energy intake (Burrows et al., 
2019). Furthermore, traditional methods are labour- and time- intensive and requires 
participants to manually record their food intake (Shim et al., 2014). Adherence dietary 
self-reporting is challenging even with mobile-based applications e.g., MyFitnessPal 
(Cordeiro et al., 2015).  
 
Wearable sensing technology is emerging to ease the procedure of food intake 
assessment. The most popular technique is accelerometer-based system, which 
captures eating gestures via monitoring wrist motions that correspond to the hand-to-
mouth movements during eating (Bell et al., 2020, He et al., 2020). The advantages 
include its simple structure and ability in capturing eating episodes and detecting time, 
speed, and duration of eating. However, this system cannot provide information about 
the energy intake and how food affects physiological response after meal. This 
knowledge is essential for determining the interaction between diet and health. 
  
Food intake and digestion increases metabolism, body temperature and intestinal 
oxygen consumption. Elevated skin temperature, increased pulse rate/ heart rate and 
lowered oxygen saturation are observed during or after meals (Westerterp, 2004, Sit 
and Chou, 1984, Sidery and Macdonald, 1994, Cassiani et al., 2011); the rise of pulse 
rate has significantly correlated to meal size (r = 0.990; P = 0.008) in six healthy 
volunteers (Parker et al., 1995). This raises the possibility of using these physiological 
responses as potential indicators of food and energy intake (Amft and Troster, 2009). 
One major problem is that the relationships can be altered by confounders such as 
exercise, while this challenge may be overcome by incorporating physiological 
parameters with existing motor sensors, which recognized eating episodes with F-
scores of 76.1% in precision and recall rates (Thomaz et al., 2015). It is hypothesized 
that integrating and physiological parameters and existing motor sensors may provide 
an objective tool for both detecting eating movement and estimating food 
consumption. 
 
 
Our project aims to investigate the relationships between physiological responses and 
food and energy intake. Importantly, these physiological parameters can be measured 
using readily available, cost-effective sensors and products (e.g., smartwatch); thus, 
our findings may promote an accelerated development of a wearable tool for dietary 
assessment in future. 
 
 
 

 
 
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2. RATIONALE FOR CURRENT STUDY 
 
Primary objective:  
 
to investigate the feasibility of monitoring dietary behaviours by tracking physiological 
changes such as skin temperature, blood oxygen saturation, pulse rate and heart rate? 
 
Secondary objectives: 
 
 To examine the association between these physiological features and energy 
loads (high vs. low-calorie meals). 
 
 To explore the relationship between these physiological features and glycaemic 
biomarkers, including blood glucose levels, insulin levels, and hormonal levels. 
 
  
3. STUDY METHODOLOGY  
 
3.1. 
 PARTICIPANTS 
10 healthy male and female participants. This is a pilot study in a new area and 
therefore a formal power calculation is not possible. 
 
3.2. 
 RECRUITMENT 
Participants will be recruited from existing healthy volunteer databases and by 
advertisement in public places. Adverts will be placed in newspapers and put up in 
public buildings. A contact number on the advert will enable potential participants to 
contact the research team at Imperial College London. Participation in the study will 
be entirely voluntary. No undue influence will be exerted by the researchers. 
Participants will be free to withdraw from the study at any time. 
 
3.3. 
 STUDY DESIGN 
 
 
Number of subjects: 10 
 
Pre-Screening Questionnaire ： 
 
A pre-screening questionnaire considering the inclusion and exclusion criteria (see 
section 3) will be completed to establish eligibility. For subjects who complete the 
questionnaire but do not continue to participate, their data will not be saved. 
Participants will have a minimum of 48 hours to consider participation before providing 
consent. 
 
Informed Consent: All participants will sign informed consent before starting the study 
(at the beginning of the 1st main study visit). 
 
 
Main Study Visits: 

 
 
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Ten healthy subjects will attend two study visits at Clinical Research Facility. They will 
consume a high- and low-calorie meal designed by nutritional researchers, in a 
randomised order. Randomization will be performed using the 'sealed envelope' 
website by an independent researcher (i.e., not linked to the study).  During eating 
events, physiological changes such as skin temperature, blood oxygen saturation, 
pulse rate etc and eating movements will be measured via a CE marked bedside 
monitor (Philips Healthcare) and non-invasive, wearable sensors. Blood samples will 
be taken at pre-determined time-points, starting 5 minutes before the meal and lasting 
for 60 minutes postprandially (at -5, +15, +30, +45, +60 min). A total of 25 ml blood 
will be taken per visit. 
 
 
Sensor Data Acquisition and Recording 
 
Participant will be invited to wear a multi-sensor monitor (please see the appendix 1 
for the diagram) and recording of physiological and activity data during eating. Sensors 
on the monitor include: 
 Skin Surface Temperature Sensors: Integrate skin surface temperature 
sensors to monitor changes in skin temperature during eating events. This data 
will provide insights into metabolic responses to food intake. 
 Pulse Rate Sensors: Employ commercial pulse rate sensors, to continuously 
monitor participants' heart rates. Variations in pulse rate can indicate the 
intensity of eating episodes and physiological responses to food. 
 Oxygen Level Sensors: Integrate oxygen level sensors, such as pulse 
oximeters, to measure blood oxygen saturation levels during eating events. 
Changes in oxygen levels can provide valuable information about participants' 
respiratory patterns and metabolic responses to food. 
 Blood Glucose Sensors: The multi-sensor monitor will be equipped with non-
invasive blood glucose sensors to continuously measure and record 
participants' blood glucose levels during eating episodes. This data is pivotal 
for understanding the impact of different foods on blood sugar regulation and 
insulin responses in individuals. 
 Movement Measurement Sensors: Inertial Measurement Units (IMU) and 
accelerometers will be used to track the posture and movement of participants' 
hands during tests and to record the features of eating behaviours. 
 Force sensors: The wearable monitor will include force sensors to monitor the 
wearing status (tightness) of the sensors themselves. Ensuring that the sensors 
are securely fastened is essential to maintain data accuracy. Force sensor data 
will serve as a quality control mechanism to guarantee that the sensors remain 
in optimal contact with the skin throughout the testing period. 
 
 
Duration 
 
End of the trial will be the last visit of the last participant in the study. The duration of 
each participant’s involvement with the study will be up to 8 weeks. Participants will 
be part of the study for two separate visits. Each visit will last for no more than two 
hours. 

 
 
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3.4. 
STUDY OUTCOME MEASURES 
 
The primary outcome is the physiological features associated with dietary events (pre- 
vs post- meal). 
 
Secondary outcomes include: 
 Physiological features associated with energy intake (high vs. low calorie 
meals). 
 Physiological features associated with glycaemic biomarkers, including blood 
glucose, insulin and hormonal levels 
 
 
4. INCLUSION/EXCLUSION CRITERIA 
 
 
4.1. 
INCLUSION CRITERIA  
 Male or female 
 Age between 18-65 years (inclusive) 
 Body mass index (BMI) of 18-30 kg/m2 
 Willingness and ability to give written informed consent.  
 Willingness and ability to understand, to participate and to comply with the 
study requirements 
 
 
4.2. 
EXCLUSION CRITERIA 
 Outside of specified age and BMI range 
 Chronic medical conditions including for eating disorders, diabetes, obesity, 
hypertension, cancer, acute infectious disease, renal disease, cardiovascular 
disease, and chronic gastrointestinal condition. 
 Taking part in another research study or donating any blood in the last 3 months 
 
4.3. 
WITHDRAWAL CRITERIA  
 
Each participant has the right to withdraw from the trial at any time. In addition, the 
Investigator may discontinue a participant from the trial at any time if the Investigator 
considers it necessary for any reason including: 
  An adverse event which requires discontinuation of the trial application or 
results in inability to continue to comply with trial procedures.  
  Loss of capacity to consent. The only reason a participant may be withdrawn 
from study follow-up is in the event of withdrawal of consent, loss of capacity to 
consent or an adverse event which in the opinion of the Investigator was related 
to the study. Participants that are withdrawn from the study will be replaced by 
eligible participants. If a patient withdraws consent or loses capacity such that 
they are unable to consent to continue in the study then data collected up until 
that point will still be used in the analysis. Reason for not completing the study 
will also be collected. Further information will not be collected from patients who 
have withdrawn from the study. 

 
 
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5. ADVERSE EVENTS  
 
5.1. 
DEFINITIONS  
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward 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 
 
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. 
 
5.2. 
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.   
 
4.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded- it should be specified if only 
some non-serious AEs will be recorded, any reporting should be consistent with the purpose 
of the trial end points.  
 
4.3.2 Serious AEs 
An SAE form should be completed and emailed to the Chief Investigator within 24 hours.  
However, relapse and death and hospitalisations for elective treatment of a pre-existing 
condition do not need reporting as SAEs. 
 
All SAEs should be reported to the London Westminster Research Ethics Committee. 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 related and unexpected SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 

 
 
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RGIT@imperial.ac.uk 
CI email (and contact details below) 
Email：m.cai18@imperial.ac.uk, attention Dr Mingzhu Cai 
Please send SAE forms to: Dr Mingzhu Cai 
Tel: 07395757128 (Mon to Fri 09.00 – 17.00) 
 
 
6. ASSESSMENT AND FOLLOW-UP  
 
There will not be follow-up visits. However, participants will be contacted via emails 
after study visits to identify incidental cases. Incidental cases will be reported to the 
GP. 
 
7. DATA STORAGE 
 
 
Data and all appropriate documentation will be stored for a minimum of 10 years after 
the completion of the study, including the follow-up period.  Data recorded by the 
wearable sensors will be transmitted to a College-owned PC terminal for storage and 
further analysis. A dedicated data logging program will be developed to ensure 
efficient data recording and storage in a secure and organized manner. Data analysis 
will be performed using College computers.  
 
 
 
8. REGULATORY ISSUES  
 
8.1. 
ETHICS APPROVAL  
The Study Coordination Centre has obtained approval from the London Westminster 
Research Ethics Committee (REC) and Health Research Authority (HRA). The study 
must also receive confirmation of capacity and capability from each participating NHS 
Trust before accepting participants into the study or any research activity is carried 
out. 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. 
 
8.2. 
CONSENT   
Consent to enter the study must be sought from each participant only after a full 
explanation has been given, an information leaflet offered and time allowed for 
consideration.  Signed participant consent should be obtained. The right of the 
participant to refuse to participate without giving reasons must be respected. After the 
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.  All participants are free to withdraw at any time from the protocol treatment 
without giving reasons and without prejudicing further treatment.   

 
 
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8.3. 
CONFIDENTIALITY  
 
Confidentiality will be maintained by pseudonymised data. Patients will be assigned 
an individual identification number from their consent form, and this will be used to 
record any further data. Signed consent forms will be kept in a locked filing cabinet in 
a locked office in the Section of Investigative Medicine, Imperial College London. 
These forms will contain the patient names and an individual study code. Patient 
contact details will be stored electronically on a password protected shared drive within 
the ICHNT network that is only available to the research team. All other data will 
contain the individual study code and no other participant identifying information. This 
will make forms pseudonymised except for the researchers. All data stored 
electronically will be password protected.  
 
 
The Chief Investigator must ensure that the subject’s confidentiality is maintained. On 
the eCRF or other documents submitted to the Sponsor, subjects will be identified by 
a subject ID number only. Documents that are not submitted to the Sponsor (e.g. 
signed informed consent form) should be kept in a strictly confidential file by the site 
investigator.  
The Chief Investigator will preserve the confidentiality of participants taking part in the 
study and is registered under the Data Protection Act. 
 
 
8.4. 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study. 
 
8.5. 
SPONSOR  
Imperial College London will act as the main Sponsor for this study.  Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
 
8.6. 
FINANCE  
 
Funding source-This study is funded by Dame Julia Higgins Postdoc Collaborative 
Research Fund. 
 
Participant payments-Participants will not be paid to participant in this study. To 
recompense to travel and time expenses, £50 will be made available for participants 
upon completion of the study. 
 
The researchers will not receive any personal payment over and above normal 
salary, or any other benefits or incentives, for taking part in this research. 
 
 
 
8.7. 
AUDITS   
The study may be subject to audit by Imperial College London under their remit as 
sponsor and other regulatory bodies to ensure adherence to GCP and the UK Policy 
Frame Work for Health and Social Care Research.  

 
 
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9. STUDY MANAGEMENT  
 
The day-to-day management of the study will be co-ordinated by Dr Mingzhu Cai. 
 
Study Management Group 
 
Chief Investigator 
  
Principal Investigator                            Dr Mingzhu Cai 
Co-investigators 
Dr Mayue Shi 
 
 
 
10. PUBLICATION POLICY  
 
The findings of the research will be presented at scientific conferences and published 
in an open-access, peer-reviewed journal. In addition, we will be collaborating with 
patient groups and professional groups to disseminate the findings via multiple media 
channels such as patient association publications, print and broadcast media. No 
participants’ identifiable data will be included. 
 
 
 

 
 
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11. REFERENCES  
 
 
AMFT, O. & TROSTER, G. 2009. On-body sensing solutions for automatic dietary 
monitoring. IEEE pervasive computing, 8, 62-70. 
BELL, B. M., ALAM, R., ALSHURAFA, N., THOMAZ, E., MONDOL, A. S., DE LA 
HAYE, K., STANKOVIC, J. A., LACH, J. & SPRUIJT-METZ, D. 2020. 
Automatic, wearable-based, in-field eating detection approaches for public 
health research: a scoping review. NPJ digital medicine, 3, 38. 
BURROWS, T. L., HO, Y. Y., ROLLO, M. E. & COLLINS, C. E. 2019. Validity of 
Dietary Assessment Methods When Compared to the Method of Doubly 
Labeled Water: A Systematic Review in Adults. Frontiers in Endocrinology, 
10. 
CASSIANI, R. D. A., SANTOS, C. M. D., MARTINEZ, J. A. B. & DANTAS, R. O. 
2011. Arterial oxygen saturation and heart rate during a meal in chronic 
obstructive pulmonary disease. International Research Journal of Pharmacy 
and Pharmacology, 1, 119-125. 
CORDEIRO, F., EPSTEIN, D. A., THOMAZ, E., BALES, E., JAGANNATHAN, A. K., 
ABOWD, G. D. & FOGARTY, J. 2015. Barriers and Negative Nudges: 
Exploring Challenges in Food Journaling. Proc SIGCHI Conf Hum Factor 
Comput Syst, 2015, 1159-1162. 
HE, S., LI, S., NAG, A., FENG, S., HAN, T., MUKHOPADHYAY, S. C. & POWEL, W. 
2020. A comprehensive review of the use of sensors for food intake detection. 
Sensors and Actuators A: Physical, 315, 112318. 
PARKER, D. R., CARLISLE, K., COWAN, F. J., CORRALL, R. J. & READ, A. E. 
1995. Postprandial mesenteric blood flow in humans: relationship to 
endogenous gastrointestinal hormone secretion and energy content of food. 
Eur J Gastroenterol Hepatol, 7, 435-40. 
SHIM, J. S., OH, K. & KIM, H. C. 2014. Dietary assessment methods in 
epidemiologic studies. Epidemiol Health, 36, e2014009. 
SIDERY, M. B. & MACDONALD, I. A. 1994. The effect of meal size on the 
cardiovascular responses to food ingestion. Br J Nutr, 71, 835-48. 
SIT, S. P. & CHOU, C. C. 1984. Time course of jejunal blood flow, O2 uptake, and 
O2 extraction during nutrient absorption. Am J Physiol, 247, H395-402. 
THOMAZ, E., ESSA, I. & ABOWD, G. D. 2015. A Practical Approach for Recognizing 
Eating Moments with Wrist-Mounted Inertial Sensing. Proc ACM Int Conf 
Ubiquitous Comput, 2015, 1029-1040. 
WESTERTERP, K. R. 2004. Diet induced thermogenesis. Nutrition & Metabolism, 1, 
5. 
 
 
 
 
 
 
 

 
 
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Appendix 1. Diagram of the multi-sensor system 
 
 
 
Each commercial sensor is originally located on a small printed circuit board (PCB) 
with a standard output port. The PCBs with sensors will be combined on the belt with 
adhesive, without changing the original wiring on the PCBs. All sensors will be 
connected to the standard input ports on the data acquisition board with jumper wires.