Energy IntakeFoodSenseNCT06398340
Identifying Wearable Biomarkers to Monitor Dietary Intake
A study testing High Calorie Meal Intervention and Low Calorie Meal Intervention in people with Energy Intake and Metabolism, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake, Metabolism, Digestion
- What is being tested?
- High Calorie Meal Intervention and Low Calorie Meal Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR Imperial College London Clinical Research Facility
London, W12 0NN
Mingzhu Cai, PhD, +44(0)7395757128, m.cai18@imperial.ac.uk
About this study
Official title: Identifying Physiological Biomarkers for Monitoring Dietary Behaviours
Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias.
Aims: This project aims to identify physiological biomarkers related to food and energy intake, which may be used to develop an objective tool to estimate individuals' food intake in future. Eating behaviours are accompanied by significant physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc. The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour, such as meal size, eating speed, and duration of meals.
Study design: Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility. Each visit will last for approximately 2 hr. They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order. During eating events, the investigators will track their physiological changes via a bedside monitor and wearable sensors. Blood samples will be taken from participants to measure their glycaemic response. Associations between energy load, glycaemic response, and physiological changes will be investigated. Our findings may promote an accelerated development of a wearable tool for dietary assessment in future.
Read the detailed description
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.
- Recruitment
Participants will be recruited from existing healthy volunteer databases and by advertisement in public places. Adverts may 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 Pre-Screening Questionnaire
A pre-screening questionnaire considering the inclusion and exclusion criteria will be completed to establish eligibility. For subjects who complete the questionnaire but do not continue to participate, their data will not be saved.
4 Informed Consent
All participants will sign informed consent before starting the study (at the beginning of the 1st main study visit).
5 Main Study Visits
Ten healthy subjects will attend two study visits at National Institute for Health and Care Research (NIHR) Imperial College London Clinical Research Facility (post code: W12 0NN, London, UK). The participants 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 bedside monitor 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.
- Conditions
- Energy Intake, Metabolism, Digestion, Wearables, Dietary Intake Assessment, Healthy Volunteers
- Being tested
- High Calorie Meal Intervention, Low Calorie Meal Intervention
- Keywords
- Dietary intake monitoring, wearable sensors, digital health, blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Calorie Meal InterventionOther
Subjects will receive a unhealthy meal high in calorie, sugar and fat
Low Calorie Meal InterventionOther
Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre
| Study group | Role | What they receive |
|---|---|---|
| High Calorie, Then Low Calorie | Experimental | Subjects will receive an unhealthy meal that against the healthy eating guidelines. After a washout period of at least 24hours, subjects will receive a balanced diet that meets healthy eating guidelines. Receives: Other: High Calorie Meal Intervention; Other: Low Calorie Meal Intervention |
| Low Calorie, Then High Calorie | Experimental | Subjects will receive a balanced diet that meets healthy eating guidelines. After a washout period of at least 24hours, subjects will receive an unhealthy meal that against the healthy eating guidelines Receives: Other: High Calorie Meal Intervention; Other: Low Calorie Meal Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of heart rate associated with dietary events (pre- vs post- meal).
Heart rate in bpm before, during and after the dietary event
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of blood pressure associated with dietary events (pre- vs post- meal).
Systolic and diastolic blood pressure in mmHg before, during and after the dietary event
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of oxygen saturation associated with dietary events (pre- vs post- meal).
Oxygen saturation in % before, during and after the dietary event
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of skin temperature associated with dietary events (pre- vs post- meal).
Skin temperature in celsius before, during and after the dietary event
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of hand movements associated with dietary events (pre- vs post- meal).
Hand movements recorded in sensors before, during and after the dietary event
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Secondary outcomes (6)
Changes of heart rate associated with energy intake (high vs. low calorie meals)
Differences on heart rate in bmp between high and low calorie meals
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of blood pressure associated with energy intake (high vs. low calorie meals)
Differences on systolic and diastolic blood pressure in mmHg between high and low calorie meals
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of heart oxygen saturation associated with energy intake (high vs. low calorie meals)
Differences on systolic and diastolic blood pressure in mmHg between high and low calorie meals
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of skin temperature associated with energy intake (high vs. low calorie meals)
Differences on skin temperature in celsius between high and low calorie meals
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of hand movements associated with energy intake (high vs. low calorie meals)
Hand movements recorded in sensors between high and low calorie meals
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Vital signs associated with blood glucose, insulin and hormonal levels
Correlation (expressed in correlation coefficient R) between vital signs (i.e., heart rate in bpm, blood pressure in mmHg, oxygen saturation in %, and skin temperature in celsius )and the blood glucose (mmol/L), insulin (mmol/L)and GIP (mmol/L) response in 60min (reported in area under curve mmol/L*min）
Measured: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start19 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy IntakeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingzhu Cai, PhD, Study chair, Nutrition Research Section, Imperial College LondonMayue Shi, PhD, Principal investigator, Department of Electrical and Electronic Engineering, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398340
- Sponsor's protocol ID
- 23HH8489
- Acronym
- FoodSense
- Status last verified
- Feb 2025
- First submitted
- 23 Apr 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi M, Zhou J, Cai M. Multiple physiological and behavioural parameters identification for dietary monitoring using wearable sensors: a study protocol. BMC Nutr. 2025 Oct 6;11(1):183. doi: 10.1186/s40795-025-01168-1.
PubMed 41053911
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Physiological Biomarkers for Monitoring Dietary Behaviours
- ClinicalTrials.gov ID
- NCT06398340
- Acronym / sponsor ID
- FoodSense / 23HH8489
- Conditions
- Energy Intake, Metabolism, Digestion, Wearables, Dietary Intake Assessment, Healthy Volunteers
- Keywords
- Dietary intake monitoring, wearable sensors, digital health, blood glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias.
Aims: This project aims to identify physiological biomarkers related to food and energy intake, which may be used to develop an objective tool to estimate individuals' food intake in future. Eating behaviours are accompanied by significant physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc. The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour, such as meal size, eating speed, and duration of meals.
Study design: Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility. Each visit will last for approximately 2 hr. They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order. During eating events, the investigators will track their physiological changes via a bedside monitor and wearable sensors. Blood samples will be taken from participants to measure their glycaemic response. Associations between energy load, glycaemic response, and physiological changes will be investigated. Our findings may promote an accelerated development of a wearable tool for dietary assessment in future.
Detailed description
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.
- Recruitment
Participants will be recruited from existing healthy volunteer databases and by advertisement in public places. Adverts may 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 Pre-Screening Questionnaire
A pre-screening questionnaire considering the inclusion and exclusion criteria will be completed to establish eligibility. For subjects who complete the questionnaire but do not continue to participate, their data will not be saved.
4 Informed Consent
All participants will sign informed consent before starting the study (at the beginning of the 1st main study visit).
5 Main Study Visits
Ten healthy subjects will attend two study visits at National Institute for Health and Care Research (NIHR) Imperial College London Clinical Research Facility (post code: W12 0NN, London, UK). The participants 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 bedside monitor 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Calorie, Then Low Calorie | Experimental | Other: High Calorie Meal Intervention, Other: Low Calorie Meal InterventionSubjects will receive an unhealthy meal that against the healthy eating guidelines. After a washout period of at least 24hours, subjects will receive a balanced diet that meets healthy eating guidelines. |
| Low Calorie, Then High Calorie | Experimental | Other: High Calorie Meal Intervention, Other: Low Calorie Meal InterventionSubjects will receive a balanced diet that meets healthy eating guidelines. After a washout period of at least 24hours, subjects will receive an unhealthy meal that against the healthy eating guidelines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Calorie Meal InterventionSubjects will receive a unhealthy meal high in calorie, sugar and fat | Other | High Calorie, Then Low Calorie, Low Calorie, Then High Calorie |
| Low Calorie Meal InterventionSubjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre | Other | High Calorie, Then Low Calorie, Low Calorie, Then High Calorie |
Primary outcome
Changes of heart rate associated with dietary events (pre- vs post- meal).
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Heart rate in bpm before, during and after the dietary event
Changes of blood pressure associated with dietary events (pre- vs post- meal).
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Systolic and diastolic blood pressure in mmHg before, during and after the dietary event
Changes of oxygen saturation associated with dietary events (pre- vs post- meal).
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Oxygen saturation in % before, during and after the dietary event
Changes of skin temperature associated with dietary events (pre- vs post- meal).
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Skin temperature in celsius before, during and after the dietary event
Changes of hand movements associated with dietary events (pre- vs post- meal).
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Hand movements recorded in sensors before, during and after the dietary event
6 secondary outcomes
Changes of heart rate associated with energy intake (high vs. low calorie meals)
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of blood pressure associated with energy intake (high vs. low calorie meals)
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of heart oxygen saturation associated with energy intake (high vs. low calorie meals)
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of skin temperature associated with energy intake (high vs. low calorie meals)
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Changes of hand movements associated with energy intake (high vs. low calorie meals)
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Vital signs associated with blood glucose, insulin and hormonal levels
Time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 41053911Shi M, Zhou J, Cai M. Multiple physiological and behavioural parameters identification for dietary monitoring using wearable sensors: a study protocol. BMC Nutr. 2025 Oct 6;11(1):183. doi: 10.1186/s40795-025-01168-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mingzhu Cai, PhD study chair
Nutrition Research Section, Imperial College London
Mayue Shi, PhD principal investigator
Department of Electrical and Electronic Engineering, Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Calorie Meal Intervention and Low Calorie Meal Intervention in people with Energy Intake and Metabolism, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingzhu Cai, PhD (+44(0)7395757128, m.cai18@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of heart rate associated with dietary events (pre- vs post- meal). (time frame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.