Identifying Wearable Biomarkers to Monitor Dietary Intake (FoodSense)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Blood Glucose; Wearables; Metabolism; Energy Intake; Digestion; Dietary Intake Assessment
• Intervention / Treatment: Other: High Calorie Meal Intervention; Other: Low Calorie Meal Intervention

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.

2. 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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingzhu Cai, PhD; Phone Number: +44(0)7395757128; Email: m.cai18@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0NN
    • Recruiting
    • NIHR Imperial College London Clinical Research Facility
    • Contact: Mingzhu Cai, PhD; Phone Number: +44(0)7395757128; Email: m.cai18@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Calorie, Then Low Calorie; 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.	Other: High Calorie Meal Intervention; Subjects will receive a unhealthy meal high in calorie, sugar and fat; Other: Low Calorie Meal Intervention; Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre
Experimental: Low Calorie, Then High Calorie; 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	Other: High Calorie Meal Intervention; Subjects will receive a unhealthy meal high in calorie, sugar and fat; Other: Low Calorie Meal Intervention; Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of heart rate associated with dietary events (pre- vs post- meal).	Heart rate in bpm before, during and after the dietary event	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	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	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	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	Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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）	Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Study Chair: Mingzhu Cai, PhD, Nutrition Research Section, Imperial College London; Principal Investigator: Mayue Shi, PhD, Department of Electrical and Electronic Engineering, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: digital health; blood glucose; wearable sensors; Dietary intake monitoring
• Other Study ID Numbers: 23HH8489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No